Pub 100-04 Medicare Claims Processing Centers for Medicare & Medicaid Services (CMS) Transmittal 10541 Date: December 31, 2020 Change Request 12120

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Department of Health & CMS Manual System Human Services (DHHS) Pub 100-04 Medicare Claims Processing Centers for Medicare & Medicaid Services (CMS) Transmittal 10541 Date: December 31, 2020 Change Request 12120

SUBJECT: January 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

I. SUMMARY OF CHANGES: This Recurring Update Notification describes changes to and billing instructions for various payment policies implemented in the January 2021 OPPS update. The January 2021 Integrated Outpatient Code Editor (I/OCE) will reflect the Healthcare Common Procedure Coding System (HCPCS), Ambulatory Payment Classification (APC), HCPCS Modifier, and Revenue Code additions, changes, and deletions identified in this Change Request (CR). This Recurring Update Notification applies to Chapter 4, section 50.7.

EFFECTIVE DATE: January 1, 2021 *Unless otherwise specified, the effective date is the date of service. IMPLEMENTATION DATE: January 4, 2021

Disclaimer for manual changes only: The revision date and transmittal number apply only to red italicized material. Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents.

II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is not updated) R=REVISED, N=NEW, D=DELETED-Only One Per Row.

R/N/D CHAPTER / SECTION / SUBSECTION / TITLE R 4/Table of Contents R 4/10.2/10.2.3/Comprehensive APCs N 4/10.2/10.2.4/Reporting for Certain Outpatient Department Services (That Are Similar to Therapy Services) (“Non-Therapy Outpatient Department Services”) and Are Adjunctive to Comprehensive APC Procedures

III. FUNDING: For Medicare Administrative Contractors (MACs): The Medicare Administrative Contractor is hereby advised that this constitutes technical direction as defined in your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the Contracting Officer. If the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notify the Contracting Officer, in writing or by e-mail, and request formal directions regarding continued performance requirements.

IV. ATTACHMENTS:

Business Requirements Manual Instruction Attachment - Business Requirements

Pub. 100-04 Transmittal: 10541 Date: December 31, 2020 Change Request: 12120

SUBJECT: January 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

EFFECTIVE DATE: January 1, 2021 *Unless otherwise specified, the effective date is the date of service. IMPLEMENTATION DATE: January 4, 2021

I. GENERAL INFORMATION

A. Background: This Recurring Update Notification describes changes to and billing instructions for various payment policies implemented in the January 2021 OPPS update. The January 2021 Integrated Outpatient Code Editor (I/OCE) will reflect the Healthcare Common Procedure Coding System (HCPCS), Ambulatory Payment Classification (APC), HCPCS Modifier, and Revenue Code additions, changes, and deletions identified in this Change Request (CR). This Recurring Update Notification applies to chapter 4, section 50.7.

The January 2021 revisions to I/OCE data files, instructions, and specifications are provided in the forthcoming January 2021 I/OCE CR.

B. Policy: 1. Covid-19 Laboratory Tests and Services Coding Update

Since February 2020, CMS has recognized several Covid-19 laboratory tests and related services. The codes are listed in Table 1, attachment A, along with their OPPS status indictors. The codes, along with their short descriptors and status indicators are also listed in the January 2021 OPPS Addendum B that is posted on the CMS website. For information on the OPPS status indicator definitions, refer to OPPS Addendum D1 of the CY 2021 OPPS/Ambulatory Surgical Center (ASC) final rule.

CMS has established one HCPCS code, U0005, effective January 1, 2021. In addition, the AMA CPT Editorial Panel established five new CPT codes, specifically, CPT codes 87636, 87637, 87811, and 0240U and 0241U effective October 6, 2020. These codes were established too late to include in the October 2020 Update, so they are included in this January 2021 Update with the effective date of October 6, 2020.

In addition, the AMA CPT Editorial Panel established CPT code 87428 effective November 10, 2020. Since it was established too late to include in the October 2020 Update, it is included in this January 2021 Update, with the effective date of November 10, 2020.

2. CPT Proprietary Laboratory Analyses (PLA) Coding Changes Effective October 6, 2020 and January 1, 2021

The AMA CPT Editorial Panel established 13 new PLA codes, specifically, CPT codes 0227U through 0239U, effective January 1, 2021. In addition, the AMA CPT Editorial Panel established two new PLA codes, specifically, CPT codes 0240U and 0241U effective October 6, 2020. Because CPT codes 0240U and 0241U were released on October 6, 2020, they were too late to include in the October 2020 OPPS update and are instead being included in the January 2021 update with an effective date of October 6, 2020. Table 2, attachment A, lists the long descriptors and status indicators for the codes.

CPT codes 0227U through 0239U have been added to the January 2021 I/OCE with an effective date of January 1, 2021 while CPT codes 0240U and 0241U have been added to the January 2021 I/OCE with an effective date of October 6, 2020. These codes, along with their short descriptors, status indicators, and payment rates (where applicable) are also listed in the January 2021 OPPS Addendum B that is posted on the CMS website. For information on the OPPS status indicators, refer to OPPS Addendum D1 of the CY 2021 OPPS/ASC final rule for the latest definitions.

3. Monoclonal Antibody Therapy Product and Administration Codes

On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab, for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.

On November 21, 2020, FDA issued an EUA for two monoclonal antibodies, specifically, casirivimab and imdevimab, that are administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.

To ensure access to these monoclonal antibody treatments during the COVID-19 public health emergency (PHE), Medicare covers and pays for the infusion of monoclonal antibody therapy in accordance with Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). That is, as a result of the circumstances of the PHE, Medicare covers and pays for the infusion of monoclonal antibody therapy in the manner in which it will pay for COVID-19 vaccines and other statutory vaccines such as influenza.

To track and pay appropriately for monoclonal antibodies used to treat COVID-19, CMS established new HCPCS codes M0239 and Q0239 effective November 9, 2020 for bamlanivimab, and new HCPCS codes M0243 and Q0243 effective November 21, 2020 for casirivimab and imdevimab. The codes have been added to the January 2021 I/OCE with their effective dates. Table 3, attachment A, lists the long descriptors for the codes. These codes, along with their short descriptors, status indicators, and payment rates (where applicable) are also listed in the January 2021 OPPS Addendum B that is posted on the CMS website.

Similar to other vaccines, Medicare will not make a separate payment to the provider for a monoclonal antibody product when that product is given to the provider for free by the government. We anticipate much of the initial volume will be supplied to providers free of charge. Medicare established HCPCS code Q0239 for bamlanivimab and HCPCS code Q0243 for casirivimab and imdevimab (administered together). If HOPDs purchase bamlanivimab or casirivimab and imdevimab, they should report HCPCS codes Q0239 or Q0243, respectively, to receive separate payment for the monoclonal antibody treatments.

Medicare will pay the provider for the administration of monoclonal antibodies regardless of whether the product is given to the provider for free. To receive separate payment for the infusion of bamlanivimab, HOPDs should report HCPCS code M0239. Similarly, to receive separate payment for the infusion of casirivimab and imdevimab, HOPDs should report HCPCS code M0243.

For more information on the Medicare Monoclonal Antibody COVID-19 Infusion Program during the Public Health Emergency, refer to the following CMS websites:

https://www.cms.gov/medicare/covid-19/monoclonal-antibody-covid-19-infusion

https://www.cms.gov/medicare/covid-19/monoclonal-antibody-covid-19-infusion#Payment

4. New Covid-19 CPT Vaccines and Administration Codes

On November 10, 2020, the AMA released six new CPT codes associated with the Pfizer and Moderna COVID-19 vaccines. Two of the six CPT codes (91300 and 91301) refer to the specific vaccine products, while the other four CPT codes (0001A, 0002A, 0011A and 0012A) describe the service to administer the vaccines. These codes will be available for use once the applicable coronavirus vaccine product receives Emergency Use Authorization (EUA) or approval from the Food and Drug Administration. The codes have been included in the January 2021 I/OCE.

In addition, on December 17, 2020, the AMA released three new CPT codes associated with the AstraZeneca and University of Oxford COVID-19 vaccine. The codes, specifically, CPT codes 91302, 0021A, and 0022A, will be available for use once the vaccine receives Emergency Use Authorization (EUA) or approval from the Food and Drug Administration.

Table 4, attachment A, lists the long descriptors for the codes. These codes, along with their short descriptors, status indicators, and payment rates (where applicable) are also listed in the January 2021 OPPS Addendum B that is posted on the CMS website. For information on the OPPS status indicators, refer to OPPS Addendum D1 of the CY 2021 OPPS/ASC final rule for the latest definitions.

For more information on the payment and effective dates for the COVID-19 vaccines and their administration during the Public Health Emergency (PHE), refer to the following CMS website:

https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and- monoclonal-antibodies

5. a. New Device Pass-Through Categories

Section 1833(t)(6)(B) of the Social Security Act requires that, under the OPPS, categories of devices be eligible for transitional pass-through payments for at least two (2), but not more than three (3) years. Section 1833(t)(6)(B)(ii)(IV) of the Act requires that we create additional categories for transitional pass-through payment of new medical devices not described by existing or previously existing categories of devices.

We are establishing three new device pass-through categories as of January 1, 2021. We are also updating the device offset from payment information for the device category described by HCPCS code C1839 (Iris prosthesis) and HCPCS code C1748 (Endoscope, single, ugi). Table 5, attachment A, provides a listing of new coding and payment information concerning the new device categories for transitional pass-through payment. b. Device Offset from Payment:

Section 1833(t)(6)(D)(ii) of the Act requires that we deduct from pass-through payments for devices an amount that reflects the device portion of the APC payment amount. This deduction is known as the device offset, or the portion(s) of the APC amount that is associated with the cost of the pass-through device. The device offset from payment represents a deduction from pass-through payments for the applicable pass- through device. i. We have determined the device offset amounts for APC 5491 Level 1 Intraocular Procedures and APC 5492 Level 2 Intraocular Procedures that are associated with the costs of the device category described by HCPCS code C1839 (Iris prosthesis). In the January 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS) (Transmittal 4513, dated February 4, 2020), we stated that the device in the category described by HCPCS C1839 should always be billed with CPT code 66999 (Unlisted procedure, anterior segment of eye). The CPT codes listed below became effective July 1, 2020 and should be billed with C1839 instead of CPT code 66999. The device in the category described by HCPCS code C1839 should always be billed with one of the following Current Procedural Terminology (CPT) codes:

• CPT code 0616T - Insertion of iris prosthesis, including suture fixation and repair or removal of iris, when performed; without removal of crystalline lens or intraocular lens, without insertion of intraocular lens, which is assigned to APC 5491 for Calendar Year (CY) 2021; • CPT code 0617T - Insertion of iris prosthesis, including suture fixation and repair or removal of iris, when performed; with removal of crystalline lens and insertion of intraocular lens, which is assigned to APC 5492 for Calendar Year (CY) 2021; • CPT code 0618T - Insertion of iris prosthesis, including suture fixation and repair or removal of iris, when performed; with secondary intraocular lens placement or intraocular lens exchange, which is assigned to APC 5492 for Calendar Year (CY) 2021;

ii. We have determined the device offset amount for APC 5465 (Level 5 Neurostimulator and Related Procedures) that is associated with the cost of the device category described by HCPCS code C1825 (Generator, neurostimulator (implantable), non-rechargeable with carotid sinus baroreceptor stimulation lead(s)). The device in the category described by HCPCS code C1825 should always be billed with one of the following Current Procedural Terminology (CPT) codes:

• CPT code 0266T (Implt/rpl crtd sns dev total), which is assigned to APC 5465 for Calendar Year (CY) 2021;

iii. We have determined the device offset amounts for APC 5302 (Level 2 Upper GI Procedures) and APC 5312 (Level 2 Lower GI Procedures) that are associated with the cost of the device category described by HCPCS code C1052 (Hemostatic agent, gastrointestinal, topical). The device in the category described by HCPCS code C1052 should always be billed with one of the following Current Procedural Terminology (CPT) codes:

• CPT code 43227 (Esophagoscopy control bleed), which is assigned to APC 5302 for Calendar Year (CY) 2021; • CPT code 43255 (Egd control bleeding any), which is assigned to APC 5302 for Calendar Year (CY) 2021; • CPT code 44366 (Small bowel endoscopy), which is assigned to APC 5302 for Calendar Year (CY) 2021; • CPT code 44378 (Small bowel endoscopy), which is assigned to APC 5302 for Calendar Year (CY) 2021; • CPT code 44391 (Colonoscopy for bleeding), which is assigned to APC 5312 for Calendar Year (CY) 2021; • CPT code 45334 (Sigmoidoscopy for bleeding), which is assigned to APC 5312 for Calendar Year (CY) 2021; • CPT code 45382 (Colonoscopy w/control bleed), which is assigned to APC 5312 for Calendar Year (CY) 2021;

iv. We have determined the device offset amount for APC 5114 (Level 4 Musculoskeletal Procedures) that is associated with the cost of the device category described by HCPCS code C1062 (Intravertebral body fracture augmentation with implant (e.g., metal, polymer). The device in the category described by HCPCS code C1062 should always be billed with one of the following Current Procedural Terminology (CPT) codes:

• CPT code 22513 (Perq vertebral augmentation), which is assigned to APC 5114 for Calendar Year (CY) 2021; • CPT code 22514 (Perq vertebral augmentation), which is assigned to APC 5114 for Calendar Year (CY) 2021;

v. On July 1, 2020, we determined that an offset would apply to C1748 (Endoscope, single-use, (i.e. disposable), Upper GI, imaging/illumination device (insertable)) because APC 5303 (Level 3 Upper GI Procedures) and APC 5331 (Complex GI Procedures) already contain costs associated with the device described by C1748. C1748 should always be billed with the CPT codes listed below. The device offset is a deduction from pass-through payments for C1748. After further review, we have determined that the costs associated with C1748 are not already reflected in APCs 5303 or 5331. Therefore, we are not applying a device offset to C1748. This determination to not apply the device offset from payment will be retroactive to July 1, 2020. See 68 FR 63438-9 for further discussion about the device offset policy.

• CPT code 43260 (Ercp w/specimen collection), which is assigned to APC 5303 for Calendar Year (CY) 2021; • CPT code 43261 (Endo cholangiopancreatograph), which is assigned to APC 5303 for Calendar Year (CY) 2021; • CPT code 43262 (Endo cholangiopancreatograph), which is assigned to APC 5303 for Calendar Year (CY) 2021; • CPT code 43263 (Ercp sphincter pressure meas), which is assigned to APC 5303 for Calendar Year (CY) 2021; • CPT code 43264 (Ercp remove duct calculi), which is assigned to APC 5303 for Calendar Year (CY) 2021; • CPT code 43265 (Ercp lithotripsy calculi), which is assigned to APC 5331 for Calendar Year (CY) 2021; • CPT code 43274 (Ercp duct stent placement), which is assigned to APC 5331 for Calendar Year (CY) 2021; • CPT code 43275 (Ercp remove forgn body duct), which is assigned to APC 5303 for Calendar Year (CY) 2021; • CPT code 43276 (Ercp stent exchange w/dilate), which is assigned to APC 5331 for Calendar Year (CY) 2021; • CPT code 43277 (Ercp ea duct/ampulla dilate), which is assigned to APC 5303 for Calendar Year (CY) 2021; • CPT code 43278 (Ercp lesion ablate w/dilate), which is assigned to APC 5303 for Calendar Year (CY) 2021;

Also, refer to https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/HospitalOutpatientPPS/passthrough_payment.html for the most current device pass-through information. c. Transitional Pass-Through Payments for Designated Devices

Certain designated new devices are assigned to APCs and identified by the I/OCE as eligible for payment based on the reasonable cost of the new device reduced by the amount included in the APC for the procedure that reflects the packaged payment for device(s) used in the procedure. The I/OCE will determine the proper payment amount for these APCs as well as the coinsurance and any applicable deductible. All related payment calculations will be returned on the same APC line and identified as a designated new device. We refer readers to Addendum P of the CY 2021 final rule with comment period for the most current OPPS HCPCS Offset file. Addendum P is available via the Internet on the CMS website. d. Alternative Pathway for Devices That Have a Food and Drug Administration (FDA) Breakthrough Designation

For devices that have received FDA marketing authorization and a Breakthrough Device designation from the FDA, CMS provided an alternative pathway to qualify for device pass-through payment status, under which devices would not be evaluated in terms of the current substantial clinical improvement criterion for the purposes of determining device pass-through payment status. The devices would still need to meet the other criteria for pass-through status. This applies to devices that receive pass-through payment status effective on or after January 1, 2020.

6. New HCPCS Code Describing the Administration of Subretinal Therapies Requiring Vitrectomy

CMS is establishing a new HCPCS code, C9770, to describe a vitrectomy, mechanical, pars plana approach, with subretinal injection of a pharmacologic or biologic agent. Table 6, attachment A, lists the official long descriptor, status indicator, and APC assignment for HCPCS code C9770. For information on OPPS status indicators, please refer to OPPS Addendum D1 of the CY 2021 OPPS/ASC final rule for the latest definitions. This code, along with its short descriptor, status indicator, and payment rate, is also listed in the January 2021 Update of the OPPS Addendum B.

7. New HCPCS Code Describing Nasal Endoscopy with Cryoablation of Nasal Tissue(s) and/or Nerve(s)

CMS is establishing HCPCS code C9771 to describe the technology associated with nasal endoscopy with cryoablation of nasal tissues and/or nerves. Table 7, attachment A, lists the long descriptor, status indicator, and APC assignment for HCPCS code C9771. For more information on OPPS status indicator “J1”, refer to OPPS Addendum D1 of the Calendar Year 2021 OPPS/ASC final rule for the latest definition. This code, along with the short descriptor, status indicator, and payment rate is also listed in the January 2021 Update of the OPPS Addendum B.

8. New HCPCS Codes Describing Peripheral Intravascular Lithotripsy (IVL) Procedures

For the January 2021 update, CMS is establishing four additional new HCPCS codes to describe the technology describing the IVL procedure, which has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood and is used for the treatment of peripheral artery disease (PAD). Specifically, CMS is establishing HCPCS code C9772, C9773, C9774, and C9775 to describe procedures utilizing IVL. We note that for the July 2020 Update, we also established HCPCS codes C9764 through C9767 to describe the IVL procedures. Table 8, attachment A, lists the long descriptors, status indicators, and APC assignments for the HCPCS codes. For more information on OPPS status indicator “J1”, refer to OPPS Addendum D1 of the Calendar Year 2021 OPPS/ASC final rule for the latest definition. We note these codes, along with their short descriptors, status indicator, and payment rates are also listed in the January 1, 2021 OPPS Addendum B.

9. Comprehensive APCs (C-APCs) a. Two New C-APCs Effective January 1, 2021

C-APCs provide a single payment for a primary service, and payment for all adjunctive services reported on the same claim is packaged into payment for the primary service. With a few exceptions, all other services reported on a hospital outpatient claim in combination with the primary service are considered to be related to the delivery of the primary service and packaged into the single payment for the primary service.

Each year, in accordance with section 1833(t)(9)(A) of the Act, we review and revise the services within each APC group and the APC assignments under the OPPS. As stated in the CY 2021 OPPS/ASC final rule with comment period, as a result of our annual review of the services and the APC assignments under the OPPS, we finalized the addition of two new C-APCs under the existing C-APC payment policy effective January 1, 2021. The new C-APCs that are effective January 1, 2021, include:

• C-APC 5378 (Level 8 Urology and Related Services) and • C-APC 5465 (Level 5 Neurostimulator and Related Procedures).

A list of these new C-APCs is found in Table 9, attachment A. The addition of these new C-APCs increases the total number of C-APCs to 69 for CY 2021. We note that Addendum J to the CY 2021 OPPS/ASC final rule with comment period contains all of the data related to the C–APC payment policy methodology, including the list of complexity adjustments and other information for CY 2021. In addition, we note that HCPCS codes assigned to comprehensive APCs are designated with status indicator “J1” in the latest OPPS Addendum B, which can be downloaded from this CMS website, specifically, at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A- and-Addendum-B-Updates.html.

b. C-APC Exclusion for COVID-19 Treatments

In the interim final with request for comments (IFC) entitled, ‘‘Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency”, published on November 6, 2020, CMS stated that effective for services furnished on or after the effective date of the IFC and until the end of the PHE for COVID-19, there is an exception to the OPPS C-APC policy to ensure separate payment for new COVID– 19 treatments that meet certain criteria (85 FR 71158 through 71160). Under this exception, any new COVID-19 treatment that meets the two following criteria will, for the remainder of the PHE for COVID- 19, always be separately paid and will not be packaged into a C-APC when it is provided on the same claim as the primary C-APC service.

First, the treatment must be a drug or biological product (which could include a blood product) authorized to treat COVID-19, as indicated in section “I. Criteria for Issuance of Authorization” of the letter of authorization for the drug or biological product, or the drug or biological product must be approved by the FDA for treating COVID-19. Second, the emergency use authorization (EUA) for the drug or biological product (which could include a blood product) must authorize the use of the product in the outpatient setting or not limit its use to the inpatient setting, or the product must be approved by the FDA to treat COVID-19 disease and not limit its use to the inpatient setting. For further information regarding the exception to the C- APC policy for COVID–19 treatments, please refer to the IFC (85 FR 71158 through 71160).

10. Changes to the Inpatient – Only List (IPO) for CY 2021

The Medicare IPO list includes procedures that are typically only provided in the inpatient setting and therefore are not paid under the OPPS. We are eliminating the IPO list over the course of a three-year period beginning in CY 2021. For CY 2021, CMS is removing 298 services from the IPO list. These changes are included in Table 10, attachment A.

11. Removal of Selected National Coverage Determinations Effective January 1, 2021

As stated in the CY 2021 Physician Fee Schedule (PFS) final rule with comment period, effective January 1, 2021, CMS removed certain National Coverage Determinations (NCD). See Table 11, attachment A, for the NCD name and manual citation.

As a result of this change, the coverage determinations for the procedures, services, and items associated with the NCDs listed above will be made by the local Medicare Administrative Contractors (MAC). In addition, we revised the status indicators for the codes listed in Table 12, attachment A, from OPPS status indicator “E1” (Not paid by Medicare when submitted on outpatient claims (any outpatient bill type)) to the status indicators and/or APCs listed in Table 12, attachment A.

12. Changes to some Opioid Treatment Program (OTP) ─ related codes.

The existing OTP-related HCPCS codes G2067-G2080 were established by CMS on January 1, 2020, and were not previously paid on the institutional claims. They were only paid on the professional claims. For CY 2021, we are allowing the OTP codes to be billed on the institutional claims only by certified OTP providers who are enrolled with Medicare as an OTP. Therefore, we are changing status indicators for G2068-G2080 from SI “E1” (Not paid by Medicare when submitted on outpatient claims (any outpatient bill type)) to SI “A” (Not paid under OPPS. Paid by MACs under a fee schedule or payment system other than OPPS) so the payment can be made on the OTP fee schedule effective January 1, 2020.

HCPCS codes G2215-G2216 were established by CMS effective January 1, 2021 and are assigned to SI “A”, similar to the existing HCPCS codes, G2067-G2080. Table 13, attachment A, lists the long descriptors and the effective dates for these codes. These codes, along with their short descriptors and status indicators, are also listed in the January 2021 Update of the OPPS Addendum B.

13. Change to the Status Indicator for HCPCS code P9099

Effective January 1, 2021, the status indicator for HCPCS code P9099 has changed from SI = “E2” (Items, codes and services for which pricing information and claims data are not available. Not paid by Medicare when submitted on outpatient claims (any outpatient bill type)) to SI = “R” (Blood and blood products that are paid under OPPS; separate APC payment) as described in Table 14, attachment A.

14. Drugs, Biologicals, and Radiopharmaceuticals

a. New CY 2021 HCPCS Codes and Dosage Descriptors for Certain Drugs, Biologicals, and Radiopharmaceuticals Receiving Pass-Through Status

Nine (9) new HCPCS codes have been created for reporting drugs and biologicals in the hospital outpatient setting, where there have not previously been specific codes available starting on January 1, 2021. These drugs and biologicals will receive drug pass-through status starting January 1, 2021. These HCPCS codes are listed in Table 15, attachment A.

b. Existing HCPCS Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals That Will Start to Receive Pass-Through Status

There are 2 existing HCPCS codes for certain drugs, biologicals, and radiopharmaceuticals in the outpatient setting that will start to receive pass-through status beginning on January 1, 2021. These HCPCS codes are listed in Table 16, attachment A.

c. Existing HCPCS Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals with Pass- Through Status Ending on December 31, 2020

There are 8 HCPCS codes for certain drugs, biologicals, and radiopharmaceuticals in the outpatient setting that will have their pass-through status end on December 31, 2020. These codes are listed in Table 17, attachment A.

d. Drugs and Biologicals that Will Retroactively Change from Non-Payable Status to Separately Payable Status from October 1, 2020 to December 31, 2020

The status indicator for HCPCS code J1437 (Injection, ferric derisomaltose, 10 mg) for the period of October 1, 2020 through December 31, 2020 will be changed retroactively from status indicator = “E2” to status indicator = “K” (Nonpass-through drugs and nonimplantable biologicals, including therapeutic radiopharmaceuticals that are paid under OPPS; separate APC payment). This drug/biological is reported in Table 18, attachment A.

e. Newly Established HCPCS Codes for Drugs, Biologicals, and Radiopharmaceuticals as of January 1, 2021

Eighteen (18) new drug, biological, and radiopharmaceutical HCPCS codes will be established on January 1, 2021. These HCPCS codes are listed in Table 19, attachment A.

f. Drugs and Biologicals with Payments Based on Average Sales Price (ASP)

For CY 2021, payment for the majority of nonpass-through drugs, biologicals and therapeutic radiopharmaceuticals that were not acquired through the 340B Program is made at a single rate of ASP + 6 percent (or ASP + 6 percent of the reference product for biosimilars). Payment for nonpass-through drugs, biologicals and therapeutic radiopharmaceuticals that were acquired under the 340B program is made at the single rate of ASP – 22.5 percent (or ASP - 22.5 percent of the biosimilar’s ASP if a biosimilar is acquired under the 340B Program), which provides payment for both the acquisition cost and pharmacy overhead costs associated with the drug, biological or therapeutic radiopharmaceutical. In CY 2021, a single payment of ASP + 6 percent for pass-through drugs, biologicals and radiopharmaceuticals is made to provide payment for both the acquisition cost and pharmacy overhead costs of these pass-through items (or ASP + 6 percent of the reference product for biosimilars). Payments for drugs and biologicals based on ASP will be updated on a quarterly basis as later quarter ASP submissions become available. Effective January 1, 2021, payment rates for many drugs and biologicals have changed from the values published in the CY 2021 OPPS/ASC final rule with comment period as a result of the new ASP calculations based on sales price submissions from second quarter of CY 2020. In cases where adjustments to payment rates are necessary, changes to the payment rates will be incorporated in the January 2021 Fiscal Intermediary Standard System (FISS) release. CMS is not publishing the updated payment rates in this Change Request implementing the January 2021 update of the OPPS. However, the updated payment rates effective January 1, 2021 can be found in the January 2021 update of the OPPS Addendum A and Addendum B on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS g. Drugs and Biologicals Based on ASP Methodology with Restated Payment Rates

Some drugs and biologicals based on ASP methodology will have payment rates that are corrected retroactively. These retroactive corrections typically occur on a quarterly basis. The list of drugs and biologicals with corrected payments rates will be accessible on the CMS website on the first date of the quarter at https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/HospitalOutpatientPPS/OPPS-Restated-Payment-Rates.html

Providers may resubmit claims that were impacted by adjustments to previous quarter’s payment files h. Restatement of the payment rate for HCPCS code A9600 (Strontium Sr-89 chloride, therapeutic, per millicurie) for the period October 1, 2020 through December 31, 2020

The payment rate of HCPCS code A9600 (Strontium sr-89 chloride, therapeutic, per millicurie) for the period of October 1, 2020 through December 31, 2020 needs to be restated. This drug/biological with the new payment rate is reported in Table 20, attachment A.

15. Skin Substitutes

The payment for skin substitute products that do not qualify for pass-through status will be packaged into the payment for the associated skin substitute application procedure. The skin substitute products are divided into two groups: 1) high cost skin substitute products and 2) low cost skin substitute products for packaging purposes. Please note that the final rule skin substitute table incorrectly assigned Q4222 (Progenamatrix, per sq cm) to the low cost group when it should have been assigned to the high cost group for January. This correction is currently reflected in all relevant January OPPS payment files and tables.

Table 21, attachment A, lists the skin substitute products and their assignment as either a high cost or a low cost skin substitute product, when applicable.

16. Reporting for Certain Outpatient Department Services (That Are Similar to Therapy Services) (“Non-Therapy Outpatient Department Services”) and Are Adjunctive to Comprehensive APC Procedures

This language was originally published in the October 2016 Update of the Outpatient Perspective Payment System (OPPS) (Transmittal 3602). We are updating this language based on the removal of the regulations at 42 CFR 410.59(a)(4) and 42 CFR 410.60(a)(4) related to functional reporting for therapy services.

Non-therapy outpatient department services are services such as physical therapy, occupational therapy, and speech-language pathology provided during the perioperative period (of a Comprehensive APC (C-APC) procedure) without a certified therapy plan of care. These are not therapy services as described in section 1834(k) of the Act, regardless of whether the services are delivered by therapists or other non-therapist health care workers. Therapy services are those provided by therapists under a plan of care in accordance with section 1835(a)(2)(C) and section 1835(a)(2)(D) of the Act and are paid for under section 1834(k) of the Act, subject to annual therapy caps as applicable (78 FR 74867 and 79 FR 66800), until they were repealed by Bipartisan Budget Act of 2018, effective January 1, 2018. Because these services are outpatient department services and not therapy services, the requirement for functional reporting under the regulations at 42 CFR 410.59(a)(4) and 42 CFR 410.60(a)(4) does not apply. The functional reporting requirements were applicable until January 1, 2019 at which time the regulations at 42 CFR 410.59(a)(4) and 42 CFR 410.60(a)(4) were removed (83 FR 41786 and 83 FR 59452).

The comprehensive APC payment policy packages payment for adjunctive items, services, and procedures into the most costly primary procedures under the OPPS at the claim level. When non-therapy outpatient department services are included on the same claim as a C-APC procedure (status indicator (SI) = J1) (see 80 FR 70326) or the specific combination of services assigned to the Observation Comprehensive APC 8011 (SI = J2), these services are considered adjunctive to the primary procedure. Payment for non-therapy outpatient department services is included as a packaged part of the payment for the C-APC procedure.

Effective for claims received on or after October 1, 2016 with dates of service on or after January 1, 2015, providers may report non-therapy outpatient department services (that are similar to therapy services) that are adjunctive to a C-APC procedure (SI = J1) or the specific combination of services assigned to the Observation Comprehensive APC 8011 (SI = J2), in one of two ways:

1. Without using the therapy CPT codes and instead reporting these non-therapy services with Revenue Code 0940 (Other Therapeutic Services); or

2. Reporting non-therapy outpatient department services that are adjunctive to J1 or J2 services with the appropriate occurrence codes, CPT codes, modifiers, and revenue codes.

17. Payment Adjustment for Certain Cancer Hospitals Beginning CY 2021

For certain cancer hospitals that receive interim monthly payments associated with the cancer hospital adjustment at 42 CFR 419.43(i), Section 16002(b) of the 21st Century Cures Act requires that, for CY 2018 and subsequent calendar years, the target Payment-to-Cost Ratio (PCR) that should be used in the calculation of the interim monthly payments and at final cost report settlement is reduced by 0.01. For CY 2021, the target PCR, after including the reduction required by Section 16002(b), is 0.89.

18. Method to Control for Unnecessary Increases in Utilization of Outpatient Services/G0463 with Modifier PO

In CY 2020, CMS finalized a policy to use our authority under section 1833(t)(2)(F) of the Act to apply an amount equal to the site-specific Physician Fee Schedule (PFS) payment rate for nonexcepted items and services furnished by a nonexcepted off-campus Provider-Based Department (PBD) (the PFS payment rate) for the clinic visit service, as described by HCPCS code G0463, when provided at an off-campus PBD excepted from section 1833(t)(21) of the Act (departments that bill the modifier “PO” on claim lines). We completed the phase-in of the policy in CY 2020.

The PFS-equivalent amount paid to nonexcepted off-campus PBDs is 40 percent of OPPS payment (that is, 60 percent less than the OPPS rate) for CY 2021. Specifically, the total 60-percent payment reduction will apply in CY 2021. In other words, these departments will be paid 40 percent of the OPPS rate (100 percent of the OPPS rate minus the 60-percent payment reduction that applies in CY 2021) for the clinic visit service in CY 2021.

19. Changes to OPPS Pricer Logic

a. Rural Sole Community Hospitals (SCH) and Essential Access Community Hospitals (EACHs) will continue to receive a 7.1 percent payment increase for most services in CY 2021. The rural SCH and EACH payment adjustment excludes drugs, biologicals, items and services paid at charges reduced to cost, and items paid under the pass-through payment policy in accordance with section 1833(t)(13)(B) of the Act, as added by section 411 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). b. New OPPS payment rates and copayment amounts will be effective January 1, 2021. All copayment amounts will be limited to a maximum of 40 percent of the APC payment rate. Copayment amounts for each service cannot exceed the CY 2021 inpatient deductible of $1,484. For most OPPS services, copayments are set at 20 percent of the APC payment rate.

c. For hospital outlier payments under OPPS, there will be no change in the multiple threshold of 1.75 for 2021. This threshold of 1.75 is multiplied by the total line-item APC payment to determine eligibility for outlier payments. This factor also is used to determine the outlier payment, which is 50 percent of estimated cost less 1.75 times the APC payment amount. The payment formula is (cost-(APC paymentx1.75))/2. d. The fixed-dollar threshold for OPPS outlier payments increases in CY 2021 relative to CY 2020. The estimated cost of a service must be greater than the APC payment amount plus $5,300 in order to qualify for outlier payments. e. For outliers for Community Mental Health Centers (bill type 76x), there will be no change in the multiple threshold of 3.4 for 2021. This threshold of 3.4 is multiplied by the total line-item APC payment for APC 5853 to determine eligibility for outlier payments. This multiple amount is also used to determine the outlier payment, which is 50 percent of estimated costs less 3.4 times the APC payment amount. The payment formula is (cost-(APC 5853 paymentx3.4))/2. f. Continuing our established policy for CY 2021, the OPPS Pricer will apply a reduced update ratio of 0.9805 to the payment and copayment for hospitals that fail to meet their hospital outpatient quality data reporting requirements or that fail to meet CMS validation edits. The reduced payment amount will be used to calculate outlier payments. g. Effective January 1, 2021, CMS is adopting the Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) post-reclassification wage index values with application of the CY 2021 out-commuting adjustment authorized by Section 505 of the MMA to non- IPPS (non-Inpatient Prospective Payment System) hospitals as implemented through the Pricer logic. h. Effective January 1, 2021, for claims with APCs, which require implantable devices and have significant device offsets (greater than 30%), a device offset cap will be applied based on the credit amount listed in the “FD” (Credit Received from the Manufacturer for a Replaced Medical Device) value code. The credit amount in value code “FD” which reduces the APC payment for the applicable procedure, will be capped by the device offset amount for that APC. The offset amounts for the above referenced APCs are available on the CMS website.

20. Update the Outpatient Provider Specific File (OPSF)

For January 1, 2021, contractors shall maintain the accuracy of the provider records in the Outpatient Provider Specific File (OPSF) as changes occur in data element values.

a) Updating the OPSF for the Supplemental Wage Index and Supplemental Wage Index Flag Fields

In CY 2020, for hospitals not listed on Table 2 or without a CY 2019 OPPS wage provided through the OPPS Pricer, MACs emailed CMS for the hospital’s CY 2020 wage index which included the wage index quartile and cap policies if applicable. Change Request 11707 (on the CMS website at https://www.cms.gov/files/document/r10121cp.pdf) created two new PSF fields, the Supplemental Wage Index and the Supplemental Wage Index Flag.

The Pricer needs a hospital’s CY 2020 OPPS wage index (or what the CY 2020 wage index would have been if the hospital existed in CY 2020) in the supplemental wage index field in order to properly apply all wage index policies and determine a hospital’s CY 2021 OPPS wage index. Therefore, for CY 2021, to accurately pay claims for providers paid through the OPPS, the Supplemental Wage Index Flag must be “1” and all OPPS providers must have a wage index in the Supplemental Wage Index field.

MACs shall ensure that no OPPS providers have a “1” or “2” in the Special Payment Indicator field and no wage index value in the Special Wage Index field with an effective date of January 1, 2021. Unless otherwise instructed by CMS, MACs must seek approval from the CMS Central Office to use a “1” or “2” in the Special Payment Indicator field and a wage index value in the Special Wage Index field.

We note that there generally are several types of assignments for the supplemental wage index that would apply under the OPPS. We note that in all of the case below the Supplemental Wage Index field would be “1” and the effective dates of such changes include for the steps outlined below would be January 1, 2021

1) If the MAC received approval from the CMS Central Office to assign an OPPS provider a special wage index in CY 2020 and the use of either “1” or “2” in the Special Payment Indicator field, MACs shall do the following

● Enter the value from the Special Wage Index for CY 2020 into the Supplemental Wage index Field.

● Enter a “1” in the Supplemental Wage Index Flag field.

● Ensure that the Special Wage Index and Special Payment Indicator fields are blank.

● Establish the record with an effective date of January 1, 2021.

2) If the MAC did not email CMS during CY 2020 for a provider’s CY 2020 wage index, then the MAC shall do the following for the case that applies:

a. IPPS hospitals that are also paid under the OPPS

For these hospitals, as described in detail in the instructions in MAC Implementation File 5 at https://www.cms.gov/medicare/acute-inpatient-pps/fy-2021-ipps-final-rule-home-page the 2020 wage index should be obtained from the Table 2 associated with the FY 2021 IPPS final rule (or Correction Notice, if applicable). In other instances in which there is an IPPS value derived through the steps outlined in the “MAC Implementation File 5” instructions document, that same FY 2020 wage index value entered into the Supplemental Wage index for the IPSF shall also be entered into the Supplemental Wage Index Field and would apply into the OPPS on a calendar year basis.

In this case MACs, shall do the following:

● Enter the value from the Special Wage Index for CY 2020 (from Table 2 or through the steps outlined in MAC Implementation File 5) into the Supplemental Wage Index Field.

● Enter a “1” in the Supplemental Wage Index Flag field.

● Ensure that the Special Wage Index and Special Payment Indicator fields are blank.

● Establish the record with an effective date of January 1, 2021.

b. Non-IPPS hospitals, CMHCs, and other OPPS providers

We have made the Supplemental Wage Index assignments (based on the CY 2020 OPPS wage index) for non-IPPS hospitals, CMHCs, and other OPPS providers available on the CMS website at www.cms.gov/HospitalOutpatientPPS/ under “Annual Policy Files.”

In this case, MACs, shall do the following:

● The CY 2020 Wage index from the Excel file available online shall be entered into the Supplemental Wage Index field.

● Enter a “1” in the Supplemental Wage Index Flag field.

● Ensure that the Special Wage Index and Special Payment Indicator fields are blank.

● Establish the record with an effective date of January 1, 2021.

c. CY 2020 Wage Index not otherwise available for Supplemental Wage Index field

Email the CMS Central Office at [email protected] requesting the calculation of the hospital’s CY 2020 wage index for assignment to the Supplemental Wage Index field. Make sure to include in your email the following: FIPS county code, the Actual Geographic Location CBSA, the Wage Index Location CBSA, the Payment CBSA, Special Payment Indicator field and the effective date in the PSF. b) Updating the OPSF for Expiration of Transitional Outpatient Payments(TOPs)

Cancer and children's hospitals are held harmless under section 1833(t)(7)(D)(ii) of the Social Security Act and continue to receive hold harmless TOPs permanently. For CY 2021, cancer hospitals will continue to receive an additional payment adjustment. c) Updating the OPSF for the Hospital Outpatient Quality Reporting (HOQR) Program Requirements

Effective for OPPS services furnished on or after January 1, 2009, subsection (d) hospitals that have failed to submit timely hospital outpatient quality data as required in Section 1833(t)(17)(A) of the Act will receive payment under the OPPS that reflects a 2 percentage point deduction from the annual OPPS update for failure to meet the HOQR program requirements. This reduction will not apply to hospitals not required to submit quality data or hospitals that are not paid under the OPPS.

For January 1, 2021, contractors shall maintain the accuracy of the provider records in the OPSF by updating the Hospital Quality Indicator field. CMS will release a Technical Direction Letter that lists Subsection (d) hospitals that are subject to and fail to meet the HOQR program requirements. Once this list is released, A/B Medicare Administrative Contractors (MACs) will update the OPSF by removing the ‘1’, (that is, ensure that the Hospital Quality Indicator field is blank) for all hospitals identified on the list and will ensure that the OPSF Hospital Quality Indicator field contains ‘1’ for all hospitals that are not on the list. CMS notes that if these hospitals are later determined to have met the HOQR program requirements, A/B MACs shall update the OPSF. For greater detail regarding updating the OPSF for the HOQR program requirements, see Transmittal 368, CR 6072, issued on August 15, 2008. d) Updating the OPSF for Cost to Charge Ratios(CCR)

As stated in publication 100-04, Medicare Claims Processing Manual, chapter 4, section 50.1, contractors must maintain the accuracy of the data and update the OPSF as changes occur in data element values, including changes to provider cost–to-charge ratios and, when applicable, device department cost-to-charge ratios. The file of OPPS hospital upper limit CCRs and the file of Statewide CCRs are located on the CMS website at www.cms.gov/HospitalOutpatientPPS/ under “Annual Policy Files.” e) Updating the “County Code”Field

Prior to CY 2018, in order to include the outmigration in a hospital’s wage index, we provided a separate table that assigned wage indexes for hospitals that received the outmigration adjustment. For the CY 2021 OPPS, the OPPS Pricer will continue to assign the out migration adjustment using the “County Code” field in the OPSF. Therefore, MACs shall ensure that every hospital has listed in the “County Code” field the Federal Information Processing Standards (FIPS) county code where the hospital is located to maintain the accuracy of the OPSF data fields. f) Updating the “Wage Index Location Core-Based Statistical Areas (CBSA)”Field

We note that under historical and current OPPS wage index policy, hospitals that have wage index reclassifications for wage adjustment purposes under the IPPS would also have those wage index reclassifications applied under the OPPS on a calendar year basis. Therefore, MACs shall ensure that wage index reclassifications applied under the FY 2021 IPPS are also reflected in the OPSF on a CY 2021 OPPS basis. g) Updating the “Payment Core-Based Statistical Areas (CBSA)”Field

In the prior layout of the OPSF, there were only two CBSA related fields: the “Actual Geographic Location CBSA” and the “Wage Index Location CBSA.” These fields are used to wage adjust OPPS payment through the Pricer if there is not an assigned Special Wage Index (as has been used historically to assign the wage index for hospitals receiving the outmigration adjustment).

In Transmittal 3750, dated April 19, 2017, for Change Request 9926, we created an additional field for the “Payment CBSA,” similar to the IPPS, to allow for consistency between the data in the two systems and identify when hospitals receive dual reclassifications. In the case of dual reclassifications, similar to the IPPS, the “Payment CBSA” field will be used to note the Urban to Rural Reclassification Under Section 1886(d)(8)(E) of the Act (§ 412.103). This “Payment CBSA” field is not used for wage adjustment purposes, but to identify when the 412.103 reclassification applies, because rural status is considered for rural sole community hospital adjustment eligibility. We further note that whereas the IPPS Pricer allows the Payment CBSA, even when applied as the sole CBSA field (without a Wage Index CBSA), to be used for wage adjusting payment, that field is not used for wage adjustment the OPPS.

21. Wage Index Policies in the CY 2021 OPPS

In the FY 2021 IPPS and CY 2021 IPPS we made the following changes to the wage index: increased the wage index values for hospitals with a wage index value below the 25th percentile wage index value of 0.8469 across all hospitals, and applied a 5 percent cap for CY 2021 on any wage index values that decreased relative to CY 2020 (implemented through the Supplemental Wage Index in the OPSF).

22.Coverage Determinations

As a reminder, the fact that a drug, device, procedure or service is assigned a HCPCS code and a payment rate under the OPPS does not imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the program. Medicare Administrative Contractors (MACs) determine whether a drug, device, procedure, or other service meets all program requirements for coverage. For example, MACs determine that it is reasonable and necessary to treat the beneficiary’s condition and whether it is excluded from payment.

II. BUSINESS REQUIREMENTS TABLE

"Shall" denotes a mandatory requirement, and "should" denotes an optional requirement.

Number Requirement Responsibility A/B MAC DME Shared-System Maintainers Other A B HHH FISS MCS VMS CWF MAC 12120 - Medicare contractors shall X X X 04.1 install the January 2021 OPPS Pricer.

12120 - Medicare contractors shall X X 04.2 adjust, as appropriate, claims brought to their attention with any retroactive changes that were received prior to implementation of the January 2021 Pricer.

12120 - As specified in chapter 4, X X 04.3 section 50.1, of the Claims Processing Manual, Medicare contractors shall maintain the accuracy of the data and update the OPSF file as changes occur in data element values. For CY 2021, this includes all changes to the OPSF identified in Section 20 of this Change Request.

III. PROVIDER EDUCATION TABLE

Number Requirement Responsibility

A/B DME CEDI MAC MAC A B HHH

12120 - MLN Article: CMS will make available an MLN Matters X X 04.4 provider education article that will be marketed through the MLN Connects weekly newsletter shortly after the CR is released. MACs shall follow IOM Pub. No. 100-09 Chapter 6, Section 50.2.4.1, instructions for distributing MLN Connects information to providers, posting the article or a direct link to the article on your website, and including the article or a direct link to the article in your bulletin or newsletter. You may supplement MLN Matters articles with localized information Number Requirement Responsibility

A/B DME CEDI MAC MAC A B HHH

benefiting your provider community in billing and administering the Medicare program correctly. Subscribe to the “MLN Matters” listserv to get article release notifications, or review them in the MLN Connects weekly newsletter.

IV. SUPPORTING INFORMATION

Section A: Recommendations and supporting information associated with listed requirements: N/A

"Should" denotes a recommendation.

X-Ref Recommendations or other supporting information: Requirement Number

Section B: All other recommendations and supporting information: N/A

V. CONTACTS

Pre-Implementation Contact(s): Marina Kushnirova, [email protected]

Post-Implementation Contact(s): Contact your Contracting Officer's Representative (COR).

VI. FUNDING

Section A: For Medicare Administrative Contractors (MACs): The Medicare Administrative Contractor is hereby advised that this constitutes technical direction as defined in your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the Contracting Officer. If the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notify the Contracting Officer, in writing or by e-mail, and request formal directions regarding continued performance requirements.

ATTACHMENTS: 1

Medicare Claims Processing Manual Chapter 4 - Part B Hospital (Including Inpatient Hospital Part B and OPPS)

Table of Contents (Rev.10541; Issued: 12-31-2020)

Transmittals for Chapter 4

10.2.4. - Reporting for Certain Outpatient Department Services (That Are Similar to Therapy Services) (“Non-Therapy Outpatient Department Services”) and Are Adjunctive to Comprehensive APC Procedures

10.2.3 - Comprehensive APCs (Rev. 10541; Issued: 12-31-20; Effective: 01-01-21; Implementation: 01-04-21)

Comprehensive APCs provide a single payment for a primary service, and payment for all adjunctive services reported on the same claim is packaged into payment for the primary service. With few exceptions, all other services reported on a hospital outpatient claim in combination with the primary service are considered to be related to the delivery of the primary service and packaged into the single payment for the primary service.

HCPCS codes assigned to comprehensive APCs are designated with status indicator J1, See Addendum B at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS for the list of HCPCS codes designated with status indicator J1.

Claims reporting at least one J1 procedure code will package the following items and services that are not typically packaged under the OPPS: • major OPPS procedure codes (status indicators P, S, T, V) • lower ranked comprehensive procedure codes (status indicator J1) • non-pass-through drugs and biologicals (status indicator K) • blood products (status indicator R) • DME (status indicator Y) • therapy services (HCPCS codes with status indicator A reported on therapy revenue centers)

The following services are excluded from comprehensive APC packaging:

• ambulance services • brachytherapy sources (status indicator U) • diagnostic and mammography screenings • physical therapy, speech-language pathology and occupational therapy services reported on a separate facility claim for recurring services • pass-through drugs, biologicals, and devices (status indicators G or H) • preventive services defined in 42 CFR410.2 • self-administered drugs (SADs) - drugs that are usually self-administered and do not function as supplies in the provision of the comprehensive service • services assigned to OPPS status indicator F (certain CRNA services, Hepatitis B vaccines and corneal tissue acquisition) • services assigned to OPPS status indicator L (influenza and pneumococcal pneumonia vaccines) • certain Part B inpatient services – Ancillary Part B inpatient services payable under Part B when the primary J1 service for the claim is not a payable Medicare Part B inpatient service (for example, exhausted Medicare Part A benefits, beneficiaries with Part B only) • services assigned to a New Technology APC • For the remainder of the PHE for COVID-19, new COVID-19 treatments that meet the following criteria: 1) The treatment must be a drug or biological product (which could include a blood product) authorized to treat COVID-19, as indicated in section “I. Criteria for Issuance of Authorization” of the letter of authorization for the drug or biological product, or the drug or biological product must be approved by the FDA for treating COVID-19 2) The emergency use authorization (EUA) for the drug or biological product (which could include a blood product) must authorize the use of the product in the outpatient setting or not limit its use to the inpatient setting, or the product must be approved by the FDA to treat COVID-19 disease and not limit its use to the inpatient setting.

The single payment for a comprehensive claim is based on the rate associated with either the J1 service or the specific combination of J2 services. When multiple J1 services are reported on the same claim, the single payment is based on the rate associated with the highest ranking J1 service. When certain pairs of J1 services (or in certain cases a J1 service and an add-on code) are reported on the same claim, the claim is eligible for a complexity adjustment, which provides a single payment for the claim based on the rate of the next higher comprehensive APC within the same clinical family. When a J1 service and a J2 service are reported on the same claim, the single payment is based on the rate associated with the J1 service, and the combination of the J1 and J2 services on the claim does not make the claim eligible for a complexity adjustment. Note that complexity adjustments will not be applied to discontinued services (reported with mod -73 or -74).

10.2.4. Reporting for Certain Outpatient Department Services (That Are Similar to Therapy Services) (“Non-Therapy Outpatient Department Services”) and Are Adjunctive to Comprehensive APC Procedures (Rev. 10541; Issued: 12-31-20; Effective: 01-01-21; Implementation: 01-04-21)

This language was originally published in the October 2016 Update of the Outpatient Perspective Payment System (OPPS) (Transmittal R3602CP). We are updating this language based on the removal of the regulations at 42 CFR 410.59(a)(4) and 42 CFR 410.60(a)(4) related to functional reporting for therapy services.

Non-therapy outpatient department services are services such as physical therapy, occupational therapy, and speech-language pathology provided during the perioperative period (of a Comprehensive APC (C- APC) procedure) without a certified therapy plan of care. These are not therapy services as described in section 1834(k) of the Act, regardless of whether the services are delivered by therapists or other non- therapist health care workers. Therapy services are those provided by therapists under a plan of care in accordance with section 1835(a)(2)(C) and section 1835(a)(2)(D) of the Act and are paid for under section 1834(k) of the Act, subject to annual therapy caps as applicable (78 FR 74867 and 79 FR 66800), until they were repealed by Bipartisan Budget Act of 2018, effective January 1, 2018. Because these services are outpatient department services and not therapy services, the requirement for functional reporting under the regulations at 42 CFR 410.59(a)(4) and 42 CFR 410.60(a)(4) does not apply. The functional reporting requirements were applicable until January 1, 2019 at which time the regulations at 42 CFR 410.59(a)(4) and 42 CFR 410.60(a)(4) were removed (83 FR 41786 and 83 FR 59452).

1. Without using the therapy CPT codes and instead reporting these non-therapy services with Revenue Code 0940 (Other Therapeutic Services); or 2. Reporting non-therapy outpatient department services that are adjunctive to J1 or J2 services with the appropriate occurrence codes, CPT codes, modifiers, and revenue codes.

Attachment A − Tables for the Policy Section

Table 1. ─ Covid-19 Laboratory Tests and Services HCPCS ata Code Long Descriptor OPPS SI OPPS APC CDC 2019 Novel Coronavirus (2019-nCoV) U0001 02/04/2020 A Real-Time RT-PCR Diagnostic Panel N/A 2019-nCoV Coronavirus, SARS-CoV-2/2019- nCoV (COVID-19), any technique, multiple N/A U0002 02/04/2020 A types or subtypes (includes all targets), non- CDC Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus N/A U0003 04/14/2020 A disease [COVID-19]), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R 2019-nCoV Coronavirus, SARS-CoV-2/2019- nCoV (COVID-19), any technique, multiple U0004 types or subtypes (includes all targets), non- 04/14/2020 A N/A CDC, making use of high throughput technologies as described by CMS-2020-01-R Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, CDC or non-CDC, making use of U0005 high throughput technologies, completed within 01/01/21 A N/A 2 calendar days from date of specimen collection (List separately in addition to either HCPCS code U0003 or U0004) as described by CMS- 2020-01-R2.

Hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome 5731 C9803 03/01/2020 Q1 coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19]), any specimen source Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) N/A G2023 03/01/2020 B (Coronavirus disease [COVID-19]), any specimen source

Specimen collection for severe acute respiratory G2024 03/01/2020 syndrome coronavirus 2 (sars-cov-2) B N/A (coronavirus disease [covid-19]) from an HCPCS ata Code Long Descriptor OPPS SI OPPS APC individual in a SNF or by a laboratory on behalf of a HHA, any specimen source

Immunoassay for infectious agent antibody, qualitative or semiquantitative, single step N/A 86328 method (eg, reagent strip); severe acute 04/10/2020 A respiratory syndrome coronavirus 2 (SARS- CoV-2) (Coronavirus disease [COVID-19]) Neutralizing antibody, severe acute respiratory 86408 syndrome coronavirus 2 (SARS-CoV-2) 08/10/2020 A N/A (Coronavirus disease [COVID-19]); screen Neutralizing antibody, severe acute respiratory 86409 syndrome coronavirus 2 (SARS-CoV-2) 08/10/2020 A N/A (Coronavirus disease [COVID-19]); titer Severe acute respiratory syndrome coronavirus 2 86413 (SARS-CoV-2) (Coronavirus disease [COVID- 09/08/2020 A N/A 19]) antibody, quantitative Antibody; severe acute respiratory syndrome 86769 coronavirus 2 (SARS-CoV-2) (Coronavirus 04/10/2020 A N/A disease [COVID-19]) Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], 87426 immunochemiluminometric assay [IMCA]) 06/25/2020 A N/A qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence 87428 immunoassay [FIA], immunochemiluminometric 11/10/2020 A N/A assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome N/A 87635 03/13/2020 A coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique HCPCS ata Code Long Descriptor OPPS SI OPPS APC Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus N/A 87636 10/06/2020 A disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus N/A 87637 disease [COVID-19]), influenza virus types A 10/06/2020 A and B, and respiratory syncytial virus, multiplex amplified probe technique Infectious agent antigen detection by immunoassay with direct optical (ie, visual) 87811 observation; severe acute respiratory syndrome 10/06/2020 A N/A coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe

0202U acute respiratory syndrome coronavirus 2 05/20/2020 N/A A (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe 0223U acute respiratory syndrome coronavirus 2 06/25/2020 A N/A (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected Antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus N/A 0224U 06/25/2020 A disease [COVID-19]), includes titer(s), when performed Infectious disease (bacterial or viral respiratory tract infection) pathogen-specific DNA and RNA, 21 targets, including severe acute A N/A respiratory syndrome coronavirus 2 (SARS- 0225U 08/10/2020 CoV-2), amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected

HCPCS ata Code Long Descriptor OPPS SI OPPS APC Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 A N/A 0226U (SARS-CoV-2) (Coronavirus disease [COVID- 08/10/2020 19]), ELISA, plasma, serum

0240U Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 3 targets (severe acute respiratory syndrome coronavirus 2 N/A 10/06/2020 A [SARS-CoV-2], influenza A, influenza B), upper respiratory specimen, each pathogen reported as detected or not detected 0241U Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 4 targets (severe acute respiratory syndrome coronavirus 2 A N/A [SARS-CoV-2], influenza A, influenza B, 10/06/2020 respiratory syncytial virus [RSV]), upper respiratory specimen, each pathogen reported as detected or not detected

Table 2. ─ PLA Coding Changes Effective October 6, 2020 and January 1, 2021 CPT OPPS Long Descriptor Code SI Drug assay, presumptive, 30 or more drugs or metabolites, urine, liquid chromatography with tandem mass spectrometry (LC-MS/MS) using 0227U Q4 multiple reaction monitoring (MRM), with drug or metabolite description, includes sample validation Oncology (prostate), multianalyte molecular profile by photometric detection of macromolecules adsorbed on nanosponge array slides with machine 0228U Q4 learning, utilizing first morning voided urine, algorithm reported as likelihood of prostate cancer BCAT1 (Branched chain amino acid transaminase 1) or IKZF1 (IKAROS 0229U A family zinc finger 1) (eg, colorectal cancer) promoter methylation analysis AR (androgen receptor) (eg, spinal and bulbar muscular atrophy, Kennedy disease, X chromosome inactivation), full sequence analysis, including small 0230U sequence changes in exonic and intronic regions, deletions, duplications, A short tandem repeat (STR) expansions, mobile element insertions, and variants in non-uniquely mappable regions CACNA1A (calcium voltage-gated channel subunit alpha 1A) (eg, spinocerebellar ataxia), full gene analysis, including small sequence changes 0231U in exonic and intronic regions, deletions, duplications, short tandem repeat A (STR) gene expansions, mobile element insertions, and variants in non- uniquely mappable regions CPT OPPS Long Descriptor Code SI CSTB (cystatin B) (eg, progressive myoclonic epilepsy type 1A, Unverricht- Lundborg disease), full gene analysis, including small sequence changes in 0232U exonic and intronic regions, deletions, duplications, short tandem repeat A (STR) expansions, mobile element insertions, and variants in non-uniquely mappable regions FXN (frataxin) (eg, Friedreich ataxia), gene analysis, including small sequence changes in exonic and intronic regions, deletions, duplications, 0233U A short tandem repeat (STR) expansions, mobile element insertions, and variants in non-uniquely mappable regions MECP2 (methyl CpG binding protein 2) (eg, Rett syndrome), full gene analysis, including small sequence changes in exonic and intronic regions, 0234U A deletions, duplications, mobile element insertions, and variants in non- uniquely mappable regions PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome), full gene analysis, including small sequence 0235U A changes in exonic and intronic regions, deletions, duplications, mobile element insertions, and variants in non-uniquely mappable regions SMN1 (survival of motor neuron 1, telomeric) and SMN2 (survival of motor neuron 2, centromeric) (eg, spinal muscular atrophy) full gene analysis, 0236U A including small sequence changes in exonic and intronic regions, duplications and deletions, and mobile element insertions Cardiac ion channelopathies (eg, Brugada syndrome, long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia), genomic sequence analysis panel including ANK2, CASQ2, 0237U CAV3, KCNE1, KCNE2, KCNH2, KCNJ2, KCNQ1, RYR2, and SCN5A, A including small sequence changes in exonic and intronic regions, deletions, duplications, mobile element insertions, and variants in non-uniquely mappable regions Oncology (Lynch syndrome), genomic DNA sequence analysis of MLH1, MSH2, MSH6, PMS2, and EPCAM, including small sequence changes in 0238U A exonic and intronic regions, deletions, duplications, mobile element insertions, and variants in non-uniquely mappable regions Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free DNA, analysis of 311 or more genes, interrogation for sequence variants, 0239U A including substitutions, insertions, deletions, select rearrangements, and copy number variations Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 3 targets (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], 0240U A influenza A, influenza B), upper respiratory specimen, each pathogen reported as detected or not detected Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 4 targets (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], 0241U A influenza A, influenza B, respiratory syncytial virus [RSV]), upper respiratory specimen, each pathogen reported as detected or not detected

Table 3. ─ Monoclonal Antibody Treatment Bamlanivimab Product and Administration Codes CPT Type Long Descriptor Code Administration/ Intravenous infusion, bamlanivimab-xxxx, includes infusion M0239 Infusion Code and post administration monitoring Q0239 Product Code Injection, bamlanivimab-xxxx, 700 mg Administration/ Intravenous infusion, casirivimab and imdevimab includes M0243 Infusion Code infusion and post administration monitoring Q0243 Product Code Injection, casirivimab and imdevimab, 2400 mg

Table 4. ─ New Covid-19 CPT Vaccines Product and Administration Codes

CPT Type Labeler Long Descriptor Code Severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) (Coronavirus disease [COVID-19]) vaccine, Vaccine/ 91300 Pfizer mRNA-LNP, spike protein, preservative free, 30 Product Code mcg/0.3mL dosage, diluent reconstituted, for intramuscular use Immunization administration by intramuscular injection Administration/ of severe acute respiratory syndrome coronavirus 2 0001A Immunization Pfizer (SARS-CoV-2) (Coronavirus disease [COVID-19]) Code vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted; first dose Immunization administration by intramuscular injection Administration/ of severe acute respiratory syndrome coronavirus 2 0002A Immunization Pfizer (SARS-CoV-2) (Coronavirus disease [COVID-19]) Code vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted; second dose Severe acute respiratory syndrome coronavirus 2 (SARS- Vaccine/ CoV-2) (Coronavirus disease [COVID-19]) vaccine, 91301 Moderna Product Code mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use Immunization administration by intramuscular injection Administration/ of severe acute respiratory syndrome coronavirus 2 0011A Immunization Moderna (SARS-CoV-2) (Coronavirus disease [COVID-19]) Code vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage; first dose Administration/ Immunization administration by intramuscular injection 0012A Immunization Moderna of severe acute respiratory syndrome coronavirus 2 Code (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage; second dose 91302 Vaccine/ AstraZeneca/ Severe acute respiratory syndrome coronavirus 2 (SARS- Product Code CoV-2) (coronavirus disease [COVID-19]) vaccine, University of DNA, spike protein, chimpanzee adenovirus Oxford 1 Oxford (ChAdOx1) vector, preservative free, 5x1010 viral particles/0.5mL dosage, for intramuscular use

0021A Administration/ AstraZeneca/ Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 Immunization University of (SARS-CoV-2) (coronavirus disease [COVID-19]) Code Oxford vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative free, 5x1010 viral particles/0.5mL dosage; first dose

0022A Administration/ AstraZeneca/ Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 Immunization University of (SARS-CoV-2) (coronavirus disease [COVID-19]) Code Oxford vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative free, 5x1010 viral particles/0.5mL dosage; second dose

Table 5. — New Device Pass-Through Codes Effective January 1, 2021

HCPCS Effective Short SI APC Long Descriptor Device Offset Amount(s) Code Date Descriptor • 0616T - $644.54 C1839 1/01/2020 H 2028 Iris prosthesis Iris prosthesis • 0617T - $1,214.50 • 0618T - $1,214.50 Generator, neurostimulator Gen, neuro, (implantable), non- C1825 01/01/2021 H 2030 carot sinus rechargeable with • CPT code 0266T – $28,190.18 baro carotid sinus baroreceptor stimulation lead(s) • CPT code 43227 - $0.00 Hemostatic • CPT code 43255 - $41.93 Hemostatic agent, C1052 01/01/2021 H 2031 agent, gi, • CPT code 44366 - $20.96 gastrointestinal, topical topic • CPT code 44378 - $45.66 • CPT code 44391 - $0.00 • CPT code 45334 - $30.80 • CPT code 45382 - $38.57

Intravertebral body • CPT code 22513 - $1308.12 Intravertebral fracture augmentation C1062 01/01/2021 H 2032 • CPT code 22514 - $1333.18 fx aug impl with implant (e.g., metal,

polymer) • CPT code 43260 – $0.00 • CPT code 43261 – $0.00 • CPT code 43262 – $0.00 Endoscope, single-use • CPT code 43263 – $0.00 (i.e. disposable), upper • CPT code 43264 – $0.00 Endoscope, C1748 07/01/2020 H 2029 gi, • single, ugi CPT code 43265 – $0.00 imaging/illumination • CPT code 43274 – $0.00 device (insertable) • CPT code 43276 – $0.00 • CPT code 43277 – $0.00 • CPT code 43278 – $0.00

Table 6. — New HCPCS Code Describing the Administration of Subretinal Therapies Requiring Vitrectomy Effective January 1, 2021

HCPCS Short Descriptor Long Descriptor SI APC Code Vitrectomy, mechanical, pars plana Vitrec/mech pars, C9770 approach, with subretinal injection of T 1561 subret inj pharmacologic/biologic agent

Table 7. — New Nasal Endoscopy with Cryoablation of Nasal Tissues and/or Nerves HCPCS Code Effective January 1, 2021 HCPCS Short Descriptor Long Descriptor SI APC Code Nasal/sinus endoscopy, cryoablation Nsl/sins cryo post C9771 nasal tissue(s) and/or nerve(s), J1 5164 nasal tis unilateral or bilateral

Table 8. — New HCPCS Codes Describing Peripheral Intravascular Lithotripsy (IVL) Procedures Effective January 1, 2021 HCPCS Short Descriptor Long Descriptor SI APC Code Revascularization, endovascular, open or percutaneous, tibial/peroneal Revasc lithotrip C9772 artery(ies), with intravascular J1 5193 tibi/perone lithotripsy, includes angioplasty within the same vessel (s), when performed Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular Revasc lithotr-stent C9773 lithotripsy, and transluminal stent J1 5194 tib/per placement(s), includes angioplasty within the same vessel(s), when performed Revascularization, endovascular, open or percutaneous, tibial/peroneal Revasc lithotr-ather artery(ies); with intravascular C9774 J1 5194 tib/per lithotripsy and atherectomy, includes angioplasty within the same vessel (s), when performed Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular Revasc lith-sten-ath C9775 lithotripsy and transluminal stent J1 5194 tib/per placement(s), and atherectomy, includes angioplasty within the same vessel (s), when performed

Table 9. — New Comprehensive APCs for CY 2021 CY 2021 APC CY 2021 APC Descriptor 5378 Level 8 Urology and Related Services 5465 Level 5 Neurostimulator and Related Procedures

Table 10. – Changes to the IPO List for CY 2021 CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 00192 Anesthesia for procedures on facial bones or Remove N N/A skull; radical surgery (including from the prognathism) IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 00474 Anesthesia for partial rib resection; radical Remove N N/A procedures (eg, pectus excavatum) from the IPO 00604 Anesthesia for procedures on cervical spine Remove N N/A and cord; procedures with patient in the from the sitting position IPO 00904 Anesthesia for; radical perineal procedure Remove N N/A from the IPO 0095T Removal of total disc arthroplasty (artificial Remove N N/A disc), anterior approach, each additional from the interspace, cervical (list separately in IPO addition to code for primary procedure) 0098T Revision including replacement of total disc Remove N N/A arthroplasty (artificial disc), anterior from the approach, each additional interspace, IPO cervical (list separately in addition to code for primary procedure) 01140 Anesthesia for interpelviabdominal Remove N N/A (hindquarter) amputation from the IPO 01150 Anesthesia for radical procedures for tumor Remove N N/A of pelvis, except hindquarter amputation from the IPO 01212 Anesthesia for open procedures involving Remove N N/A hip joint; hip disarticulation from the IPO 01232 Anesthesia for open procedures involving Remove N N/A upper two-thirds of femur; amputation from the IPO 01234 Anesthesia for open procedures involving Remove N N/A upper two-thirds of femur; radical resection from the IPO 01274 Anesthesia for procedures involving arteries Remove N N/A of upper leg, including bypass graft; femoral from the artery embolectomy IPO 01404 Anesthesia for open or surgical arthroscopic Remove N N/A procedures on knee joint; disarticulation at from the knee IPO 01486 Anesthesia for open procedures on bones of Remove N N/A lower leg, ankle, and foot; total ankle from the replacement IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 0163T Total disc arthroplasty (artificial disc), Remove N N/A anterior approach, including discectomy to from the prepare interspace (other than for IPO decompression), each additional interspace, lumbar (list separately in addition to code for primary procedure) 01634 Anesthesia for open or surgical arthroscopic Remove N N/A procedures on humeral head and neck, from the sternoclavicular joint, acromioclavicular IPO joint, and shoulder joint; shoulder disarticulation 01636 Anesthesia for open or surgical arthroscopic Remove N N/A procedures on humeral head and neck, from the sternoclavicular joint, acromioclavicular IPO joint, and shoulder joint; interthoracoscapular (forequarter) amputation 01638 Anesthesia for open or surgical arthroscopic Remove N N/A procedures on humeral head and neck, from the sternoclavicular joint, acromioclavicular IPO joint, and shoulder joint; total shoulder replacement 0164T Removal of total disc arthroplasty, (artificial Remove N N/A disc), anterior approach, each additional from the interspace, lumbar (list separately in IPO addition to code for primary procedure) 0165T Revision including replacement of total disc Remove N N/A arthroplasty (artificial disc), anterior from the approach, each additional interspace, lumbar IPO (list separately in addition to code for primary procedure) 01756 Anesthesia for open or surgical arthroscopic Remove N N/A procedures of the elbow; radical procedures from the IPO 0202T Posterior vertebral joint(s) arthroplasty (eg, Remove J1 5115 facet joint[s] replacement), including from the facetectomy, laminectomy, foraminotomy, IPO and vertebral column fixation, injection of bone cement, when performed, including fluoroscopy, single level, lumbar spine CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 0219T Placement of a posterior intrafacet Remove J1 5115 implant(s), unilateral or bilateral, including from the imaging and placement of bone graft(s) or IPO synthetic device(s), single level; cervical 0220T Placement of a posterior intrafacet Remove J1 5115 implant(s), unilateral or bilateral, including from the imaging and placement of bone graft(s) or IPO synthetic device(s), single level; thoracic 20661 Application of halo, including removal; Remove Q1 5113 cranial from the IPO 20664 Application of halo, including removal, Remove Q1 5113 cranial, 6 or more pins placed, for thin skull from the osteology (eg, pediatric patients, IPO hydrocephalus, osteogenesis imperfecta) 20802 Replantation, arm (includes surgical neck of Remove J1 5116 humerus through elbow joint), complete from the amputation IPO 20805 Replantation, forearm (includes radius and Remove J1 5116 ulna to radial carpal joint), complete from the amputation IPO 20808 Replantation, hand (includes hand through Remove J1 5116 metacarpophalangeal joints), complete from the amputation IPO 20816 Replantation, digit, excluding thumb Remove J1 5114 (includes metacarpophalangeal joint to from the insertion of flexor sublimis tendon), IPO complete amputation 20824 Replantation, thumb (includes Remove J1 5114 carpometacarpal joint to mp joint), complete from the amputation IPO 20827 Replantation, thumb (includes distal tip to Remove J1 5114 mp joint), complete amputation from the IPO 20838 Replantation, foot, complete amputation Remove J1 5116 from the IPO 20955 Bone graft with microvascular anastomosis; Remove J1 5114 fibula from the IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 20956 Bone graft with microvascular anastomosis; Remove J1 5114 iliac crest from the IPO 20957 Bone graft with microvascular anastomosis; Remove J1 5114 metatarsal from the IPO 20962 Bone graft with microvascular anastomosis; Remove J1 5114 other than fibula, iliac crest, or metatarsal from the IPO 20969 Free osteocutaneous flap with microvascular Remove J1 5114 anastomosis; other than iliac crest, from the metatarsal, or great toe IPO 20970 Free osteocutaneous flap with microvascular Remove J1 5114 anastomosis; iliac crest from the IPO 21045 Excision of malignant tumor of mandible; Remove J1 5165 radical resection from the IPO 21141 Reconstruction midface, lefort i; single Remove J1 5165 piece, segment movement in any direction from the (eg, for long face syndrome), without bone IPO graft 21142 Reconstruction midface, lefort i; 2 pieces, Remove J1 5165 segment movement in any direction, from the without bone graft IPO 21143 Reconstruction midface, lefort i; 3 or more Remove J1 5165 pieces, segment movement in any direction, from the without bone graft IPO 21145 Reconstruction midface, lefort i; single Remove J1 5165 piece, segment movement in any direction, from the requiring bone grafts (includes obtaining IPO autografts) 21146 Reconstruction midface, lefort i; 2 pieces, Remove J1 5165 segment movement in any direction, from the requiring bone grafts (includes obtaining IPO autografts) (eg, ungrafted unilateral alveolar cleft) 21147 Reconstruction midface, lefort i; 3 or more Remove J1 5165 pieces, segment movement in any direction, from the requiring bone grafts (includes obtaining IPO autografts) (eg, ungrafted bilateral alveolar cleft or multiple osteotomies) CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 21151 Reconstruction midface, lefort ii; any Remove J1 5165 direction, requiring bone grafts (includes from the obtaining autografts) IPO 21154 Reconstruction midface, lefort iii Remove J1 5165 (extracranial), any type, requiring bone from the grafts (includes obtaining autografts); IPO without lefort i 21155 Reconstruction midface, lefort iii Remove J1 5165 (extracranial), any type, requiring bone from the grafts (includes obtaining autografts); with IPO lefort i 21159 Reconstruction midface, lefort iii (extra and Remove J1 5165 intracranial) with forehead advancement from the (eg, mono bloc), requiring bone grafts IPO (includes obtaining autografts); without lefort i 21160 Reconstruction midface, lefort iii (extra and Remove J1 5165 intracranial) with forehead advancement from the (eg, mono bloc), requiring bone grafts IPO (includes obtaining autografts); with lefort i 21179 Reconstruction, entire or majority of Remove J1 5165 forehead and/or supraorbital rims; with from the grafts (allograft or prosthetic material) IPO 21180 Reconstruction, entire or majority of Remove J1 5165 forehead and/or supraorbital rims; with from the autograft (includes obtaining grafts) IPO 21182 Reconstruction of orbital walls, rims, Remove J1 5165 forehead, nasoethmoid complex following from the intra- and extracranial excision of benign IPO tumor of cranial bone (eg, fibrous dysplasia), with multiple autografts (includes obtaining grafts); total area of bone grafting less than 40 sq cm 21183 Reconstruction of orbital walls, rims, Remove J1 5165 forehead, nasoethmoid complex following from the intra- and extracranial excision of benign IPO tumor of cranial bone (eg, fibrous dysplasia), with multiple autografts (includes obtaining grafts); total area of bone grafting greater than 40 sq cm but less than 80 sq cm CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 21184 Reconstruction of orbital walls, rims, Remove J1 5165 forehead, nasoethmoid complex following from the intra- and extracranial excision of benign IPO tumor of cranial bone (eg, fibrous dysplasia), with multiple autografts (includes obtaining grafts); total area of bone grafting greater than 80 sq cm 21188 Reconstruction midface, osteotomies (other Remove J1 5165 than lefort type) and bone grafts (includes from the obtaining autografts) IPO 21194 Reconstruction of mandibular rami, Remove J1 5165 horizontal, vertical, c, or l osteotomy; with from the bone graft (includes obtaining graft) IPO 21196 Reconstruction of mandibular rami and/or Remove J1 5165 body, sagittal split; with internal rigid from the fixation IPO 21247 Reconstruction of mandibular condyle with Remove J1 5165 bone and cartilage autografts (includes from the obtaining grafts) (eg, for hemifacial IPO microsomia) 21255 Reconstruction of zygomatic arch and Remove J1 5165 glenoid fossa with bone and cartilage from the (includes obtaining autografts) IPO 21268 Orbital repositioning, periorbital Remove J1 5165 osteotomies, unilateral, with bone grafts; from the combined intra- and extracranial approach IPO 21343 Open treatment of depressed frontal sinus Remove J1 5165 fracture from the IPO 21344 Open treatment of complicated (eg, Remove J1 5165 comminuted or involving posterior wall) from the frontal sinus fracture, via coronal or IPO multiple approaches 21347 Open treatment of nasomaxillary complex Remove J1 5165 fracture (lefort ii type); requiring multiple from the open approaches IPO 21348 Open treatment of nasomaxillary complex Remove J1 5165 fracture (lefort ii type); with bone grafting from the (includes obtaining graft) IPO 21366 Open treatment of complicated (eg, Remove J1 5165 comminuted or involving cranial nerve from the foramina) fracture(s) of malar area, IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator including zygomatic arch and malar tripod; with bone grafting (includes obtaining graft) 21422 Open treatment of palatal or maxillary Remove J1 5165 fracture (lefort i type); from the IPO 21423 Open treatment of palatal or maxillary Remove J1 5165 fracture (lefort i type); complicated from the (comminuted or involving cranial nerve IPO foramina), multiple approaches 21431 Closed treatment of craniofacial separation Remove J1 5165 (lefort iii type) using interdental wire from the fixation of denture or splint IPO 21432 Open treatment of craniofacial separation Remove J1 5165 (lefort iii type); with wiring and/or internal from the fixation IPO 21433 Open treatment of craniofacial separation Remove J1 5165 (lefort iii type); complicated (eg, from the comminuted or involving cranial nerve IPO foramina), multiple surgical approaches 21435 Open treatment of craniofacial separation Remove J1 5165 (lefort iii type); complicated, utilizing from the internal and/or external fixation techniques IPO (eg, head cap, halo device, and/or intermaxillary fixation) 21436 Open treatment of craniofacial separation Remove J1 5165 (lefort iii type); complicated, multiple from the surgical approaches, internal fixation, with IPO bone grafting (includes obtaining graft) 21510 Incision, deep, with opening of bone cortex Remove J1 5114 (eg, for osteomyelitis or bone abscess), from the thorax IPO 21602 Excision of chest wall tumor involving Remove J1 5114 rib(s), with plastic reconstruction; without from the mediastinal lymphadenectomy IPO 21603 Excision of chest wall tumor involving Remove J1 5114 rib(s), with plastic reconstruction; with from the mediastinal lymphadenectomy IPO 21615 Excision first and/or cervical rib; Remove J1 5114 from the IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 21616 Excision first and/or cervical rib; with Remove J1 5114 sympathectomy from the IPO 21620 Ostectomy of sternum, partial Remove J1 5114 from the IPO 21627 Sternal debridement Remove J1 5114 from the IPO 21630 Radical resection of sternum; Remove J1 5114 from the IPO 21632 Radical resection of sternum; with Remove J1 5114 mediastinal lymphadenectomy from the IPO 21705 Division of scalenus anticus; with resection Remove J1 5114 of cervical rib from the IPO 21740 Reconstructive repair of pectus excavatum Remove J1 5114 or carinatum; open from the IPO 21750 Closure of median sternotomy separation Remove J1 5114 with or without debridement (separate from the procedure) IPO 21825 Open treatment of sternum fracture with or Remove J1 5114 without skeletal fixation from the IPO 22010 Incision and drainage, open, of deep abscess Remove J1 5114 (subfascial), posterior spine; cervical, from the thoracic, or cervicothoracic IPO 22015 Incision and drainage, open, of deep abscess Remove J1 5114 (subfascial), posterior spine; lumbar, sacral, from the or lumbosacral IPO 22110 Partial excision of vertebral body, for Remove J1 5114 intrinsic bony lesion, without from the decompression of spinal cord or nerve IPO root(s), single vertebral segment; cervical 22112 Partial excision of vertebral body, for Remove J1 5114 intrinsic bony lesion, without from the decompression of spinal cord or nerve IPO root(s), single vertebral segment; thoracic CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 22114 Partial excision of vertebral body, for Remove J1 5114 intrinsic bony lesion, without from the decompression of spinal cord or nerve IPO root(s), single vertebral segment; lumbar 22116 Partial excision of vertebral body, for Remove N N/A intrinsic bony lesion, without from the decompression of spinal cord or nerve IPO root(s), single vertebral segment; each additional vertebral segment (list separately in addition to code for primary procedure) 22206 Osteotomy of spine, posterior or Remove J1 5114 posterolateral approach, 3 columns, 1 from the vertebral segment (eg, pedicle/vertebral IPO body subtraction); thoracic 22207 Osteotomy of spine, posterior or Remove J1 5114 posterolateral approach, 3 columns, 1 from the vertebral segment (eg, pedicle/vertebral IPO body subtraction); lumbar

22208 Osteotomy of spine, posterior or Remove N N/A posterolateral approach, 3 columns, 1 from the vertebral segment (eg, pedicle/vertebral IPO body subtraction); each additional vertebral segment (list separately in addition to code for primary procedure) 22210 Osteotomy of spine, posterior or Remove J1 5114 posterolateral approach, 1 vertebral from the segment; cervical IPO 22212 Osteotomy of spine, posterior or Remove J1 5114 posterolateral approach, 1 vertebral from the segment; thoracic IPO 22214 Osteotomy of spine, posterior or Remove J1 5114 posterolateral approach, 1 vertebral from the segment; lumbar IPO 22216 Osteotomy of spine, posterior or Remove N N/A posterolateral approach, 1 vertebral from the segment; each additional vertebral segment IPO (list separately in addition to primary procedure) 22220 Osteotomy of spine, including discectomy, Remove J1 5114 anterior approach, single vertebral segment; from the cervical IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 22222 Osteotomy of spine, including discectomy, Remove J1 5114 anterior approach, single vertebral segment; from the thoracic IPO 22224 Osteotomy of spine, including discectomy, Remove J1 5114 anterior approach, single vertebral segment; from the lumbar IPO 22226 Osteotomy of spine, including discectomy, Remove N N/A anterior approach, single vertebral segment; from the each additional vertebral segment (list IPO separately in addition to code for primary procedure) 22318 Open treatment and/or reduction of Remove J1 5115 odontoid fracture(s) and or dislocation(s) from the (including os odontoideum), anterior IPO approach, including placement of internal fixation; without grafting 22319 Open treatment and/or reduction of Remove J1 5115 odontoid fracture(s) and or dislocation(s) from the (including os odontoideum), anterior IPO approach, including placement of internal fixation; with grafting 22325 Open treatment and/or reduction of Remove J1 5115 vertebral fracture(s) and/or dislocation(s), from the posterior approach, 1 fractured vertebra or IPO dislocated segment; lumbar 22326 Open treatment and/or reduction of Remove J1 5115 vertebral fracture(s) and/or dislocation(s), from the posterior approach, 1 fractured vertebra or IPO dislocated segment; cervical 22327 Open treatment and/or reduction of Remove J1 5115 vertebral fracture(s) and/or dislocation(s), from the posterior approach, 1 fractured vertebra or IPO dislocated segment; thoracic 22328 Open treatment and/or reduction of Remove N N/A vertebral fracture(s) and/or dislocation(s), from the posterior approach, 1 fractured vertebra or IPO dislocated segment; each additional fractured vertebra or dislocated segment (list separately in addition to code for primary procedure) CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 22532 Arthrodesis, lateral extracavitary technique, Remove J1 5116 including minimal discectomy to prepare from the interspace (other than for decompression); IPO thoracic 22533 Arthrodesis, lateral extracavitary technique, Remove J1 5116 including minimal discectomy to prepare from the interspace (other than for decompression); IPO lumbar 22534 Arthrodesis, lateral extracavitary technique, Remove N N/A including minimal discectomy to prepare from the interspace (other than for decompression); IPO thoracic or lumbar, each additional vertebral segment (list separately in addition to code for primary procedure) 22548 Arthrodesis, anterior transoral or extraoral Remove J1 5116 technique, clivus-c1-c2 (atlas-axis), with or from the without excision of odontoid process IPO 22556 Arthrodesis, anterior interbody technique, Remove J1 5116 including minimal discectomy to prepare from the interspace (other than for decompression); IPO thoracic 22558 Arthrodesis, anterior interbody technique, Remove J1 5116 including minimal discectomy to prepare from the interspace (other than for decompression); IPO lumbar 22586 Arthrodesis, pre-sacral interbody technique, Remove J1 5116 including disc space preparation, from the discectomy, with posterior instrumentation, IPO with image guidance, includes bone graft when performed, l5-s1 interspace 22590 Arthrodesis, posterior technique, Remove J1 5116 craniocervical (occiput-c2) from the IPO 22595 Arthrodesis, posterior technique, atlas-axis Remove J1 5116 (c1-c2) from the IPO 22600 Arthrodesis, posterior or posterolateral Remove J1 5116 technique, single level; cervical below c2 from the segment IPO 22610 Arthrodesis, posterior or posterolateral Remove J1 5116 technique, single level; thoracic (with lateral from the transverse technique, when performed) IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 22630 Arthrodesis, posterior interbody technique, Remove J1 5116 including laminectomy and/or discectomy from the to prepare interspace (other than for IPO decompression), single interspace; lumbar 22632 Arthrodesis, posterior interbody technique, Remove N N/A including laminectomy and/or discectomy from the to prepare interspace (other than for IPO decompression), single interspace; each additional interspace (list separately in addition to code for primary procedure) 22800 Arthrodesis, posterior, for spinal deformity, Remove J1 5116 with or without cast; up to 6 vertebral from the segments IPO 22802 Arthrodesis, posterior, for spinal deformity, Remove J1 5116 with or without cast; 7 to 12 vertebral from the segments IPO 22804 Arthrodesis, posterior, for spinal deformity, Remove J1 5116 with or without cast; 13 or more vertebral from the segments IPO 22808 Arthrodesis, anterior, for spinal deformity, Remove J1 5116 with or without cast; 2 to 3 vertebral from the segments IPO 22810 Arthrodesis, anterior, for spinal deformity, Remove J1 5116 with or without cast; 4 to 7 vertebral from the segments IPO 22812 Arthrodesis, anterior, for spinal deformity, Remove J1 5116 with or without cast; 8 or more vertebral from the segments IPO 22818 Kyphectomy, circumferential exposure of Remove J1 5116 spine and resection of vertebral segment(s) from the (including body and posterior elements); IPO single or 2 segments 22819 Kyphectomy, circumferential exposure of Remove J1 5116 spine and resection of vertebral segment(s) from the (including body and posterior elements); 3 IPO or more segments 22830 Exploration of spinal fusion Remove J1 5115 from the IPO 22841 Internal spinal fixation by wiring of spinous Remove N N/A processes (list separately in addition to code from the for primary procedure) IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 22843 Posterior segmental instrumentation (eg, Remove N N/A pedicle fixation, dual rods with multiple from the hooks and sublaminar wires); 7 to 12 IPO vertebral segments (list separately in addition to code for primary procedure) 22844 Posterior segmental instrumentation (eg, Remove N N/A pedicle fixation, dual rods with multiple from the hooks and sublaminar wires); 13 or more IPO vertebral segments (list separately in addition to code for primary procedure) 22846 Anterior instrumentation; 4 to 7 vertebral Remove N N/A segments (list separately in addition to code from the for primary procedure) IPO 22847 Anterior instrumentation; 8 or more Remove N N/A vertebral segments (list separately in from the addition to code for primary procedure) IPO 22848 Pelvic fixation (attachment of caudal end of Remove N N/A instrumentation to pelvic bony structures) from the other than sacrum (list separately in addition IPO to code for primary procedure) 22849 Reinsertion of spinal fixation device Remove J1 5116 from the IPO 22850 Removal of posterior nonsegmental Remove J1 5115 instrumentation (eg, harrington rod) from the IPO 22852 Removal of posterior segmental Remove J1 5115 instrumentation from the IPO 22855 Removal of anterior instrumentation Remove J1 5115 from the IPO 22857 Total disc arthroplasty (artificial disc), Remove J1 5116 anterior approach, including discectomy to from the prepare interspace (other than for IPO decompression), single interspace, lumbar 22861 Revision including replacement of total disc Remove J1 5116 arthroplasty (artificial disc), anterior from the approach, single interspace; cervical IPO 22862 Revision including replacement of total disc Remove J1 5116 arthroplasty (artificial disc), anterior from the approach, single interspace; lumbar IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 22864 Removal of total disc arthroplasty (artificial Remove J1 5115 disc), anterior approach, single interspace; from the cervical IPO 22865 Removal of total disc arthroplasty (artificial Remove J1 5115 disc), anterior approach, single interspace; from the lumbar IPO 23200 Radical resection of tumor; clavicle Remove J1 5114 from the IPO 23210 Radical resection of tumor; scapula Remove J1 5114 from the IPO 23220 Radical resection of tumor, proximal Remove J1 5114 humerus from the IPO 23335 Removal of prosthesis, includes Remove J1 5073 debridement and synovectomy when from the performed; humeral and glenoid IPO components (eg, total shoulder) 23472 Arthroplasty, glenohumeral joint; total Remove J1 5115 shoulder (glenoid and proximal humeral from the replacement (eg, total shoulder)) IPO 23474 Revision of total shoulder arthroplasty, Remove J1 5115 including allograft when performed; from the humeral and glenoid component IPO 23900 Interthoracoscapular amputation Remove J1 5115 (forequarter) from the IPO 23920 Disarticulation of shoulder; Remove J1 5115 from the IPO 24900 Amputation, arm through humerus; with Remove J1 5115 primary closure from the IPO 24920 Amputation, arm through humerus; open, Remove J1 5115 circular (guillotine) from the IPO 24930 Amputation, arm through humerus; re- Remove J1 5114 amputation from the IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 24931 Amputation, arm through humerus; with Remove J1 5115 implant from the IPO 24940 Cineplasty, upper extremity, complete Remove J1 5115 procedure from the IPO 25900 Amputation, forearm, through radius and Remove J1 5115 ulna; from the IPO 25905 Amputation, forearm, through radius and Remove J1 5115 ulna; open, circular (guillotine) from the IPO 25915 Krukenberg procedure Remove J1 5114 from the IPO 25920 Disarticulation through wrist; Remove J1 5114 from the IPO 25924 Disarticulation through wrist; re-amputation Remove J1 5114 from the IPO 25927 Transmetacarpal amputation; Remove J1 5113 from the IPO 26551 Transfer, toe-to-hand with microvascular Remove J1 5114 anastomosis; great toe wrap-around with from the bone graft IPO 26553 Transfer, toe-to-hand with microvascular Remove J1 5114 anastomosis; other than great toe, single from the IPO 26554 Transfer, toe-to-hand with microvascular Remove J1 5114 anastomosis; other than great toe, double from the IPO 26556 Transfer, free toe joint, with microvascular Remove J1 5114 anastomosis from the IPO 26992 Incision, bone cortex, pelvis and/or hip joint Remove J1 5114 (eg, osteomyelitis or bone abscess) from the IPO 27005 Tenotomy, hip flexor(s), open (separate Remove J1 5114 procedure) from the IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 27025 Fasciotomy, hip or thigh, any type Remove J1 5114 from the IPO 27030 Arthrotomy, hip, with drainage (eg, Remove J1 5114 infection) from the IPO 27036 Capsulectomy or capsulotomy, hip, with or Remove J1 5114 without excision of heterotopic bone, with from the release of hip flexor muscles (ie, gluteus IPO medius, gluteus minimus, tensor fascia latae, rectus femoris, sartorius, iliopsoas) 27054 Arthrotomy with synovectomy, hip joint Remove J1 5113 from the IPO 27070 Partial excision, wing of ilium, symphysis Remove J1 5114 pubis, or greater trochanter of femur, from the (craterization, saucerization) (eg, IPO osteomyelitis or bone abscess); superficial

27071 Partial excision, wing of ilium, symphysis Remove J1 5114 pubis, or greater trochanter of femur, from the (craterization, saucerization) (eg, IPO osteomyelitis or bone abscess); deep (subfascial or intramuscular)

27075 Radical resection of tumor; wing of ilium, 1 Remove J1 5114 pubic or ischial ramus or symphysis pubis from the IPO 27076 Radical resection of tumor; ilium, including Remove J1 5114 acetabulum, both pubic rami, or ischium from the and acetabulum IPO 27077 Radical resection of tumor; innominate Remove J1 5115 bone, total from the IPO 27078 Radical resection of tumor; ischial Remove J1 5115 tuberosity and greater trochanter of femur from the IPO 27090 Removal of hip prosthesis; (separate Remove J1 5073 procedure) from the IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 27091 Removal of hip prosthesis; complicated, Remove J1 5073 including total hip prosthesis, from the methylmethacrylate with or without IPO insertion of spacer 27120 Acetabuloplasty; (eg, whitman, colonna, Remove J1 5115 haygroves, or cup type) from the IPO 27122 Acetabuloplasty; resection, femoral head Remove J1 5115 (eg, girdlestone procedure) from the IPO 27125 Hemiarthroplasty, hip, partial (eg, femoral Remove J1 5115 stem prosthesis, bipolar arthroplasty) from the IPO 27132 Conversion of previous hip surgery to total Remove J1 5115 hip arthroplasty, with or without autograft from the or allograft IPO 27134 Revision of total hip arthroplasty; both Remove J1 5115 components, with or without autograft or from the allograft IPO 27137 Revision of total hip arthroplasty; acetabular Remove J1 5115 component only, with or without autograft from the or allograft IPO 27138 Revision of total hip arthroplasty; femoral Remove J1 5115 component only, with or without allograft from the IPO 27140 Osteotomy and transfer of greater trochanter Remove J1 5115 of femur (separate procedure) from the IPO 27146 Osteotomy, iliac, acetabular or innominate Remove J1 5114 bone; from the IPO 27147 Osteotomy, iliac, acetabular or innominate Remove J1 5114 bone; with open reduction of hip from the IPO 27151 Osteotomy, iliac, acetabular or innominate Remove J1 5114 bone; with femoral osteotomy from the IPO 27156 Osteotomy, iliac, acetabular or innominate Remove J1 5114 bone; with femoral osteotomy and with from the open reduction of hip IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 27158 Osteotomy, pelvis, bilateral (eg, congenital Remove J1 5114 malformation) from the IPO 27161 Osteotomy, femoral neck (separate Remove J1 5114 procedure) from the IPO 27165 Osteotomy, intertrochanteric or Remove J1 5114 subtrochanteric including internal or from the external fixation and/or cast IPO 27170 Bone graft, femoral head, neck, Remove J1 5114 intertrochanteric or subtrochanteric area from the (includes obtaining bone graft) IPO 27175 Treatment of slipped femoral epiphysis; by Remove J1 5114 traction, without reduction from the IPO 27176 Treatment of slipped femoral epiphysis; by Remove J1 5115 single or multiple pinning, in situ from the IPO 27177 Open treatment of slipped femoral Remove J1 5114 epiphysis; single or multiple pinning or from the bone graft (includes obtaining graft) IPO 27178 Open treatment of slipped femoral Remove J1 5114 epiphysis; closed manipulation with single from the or multiple pinning IPO 27181 Open treatment of slipped femoral Remove J1 5114 epiphysis; osteotomy and internal fixation from the IPO 27185 Epiphyseal arrest by epiphysiodesis or Remove J1 5114 stapling, greater trochanter of femur from the IPO 27187 Prophylactic treatment (nailing, pinning, Remove J1 5114 plating or wiring) with or without from the methylmethacrylate, femoral neck and IPO proximal femur 27222 Closed treatment of acetabulum (hip socket) Remove J1 5111 fracture(s); with manipulation, with or from the without skeletal traction IPO 27226 Open treatment of posterior or anterior Remove J1 5114 acetabular wall fracture, with internal from the fixation IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 27227 Open treatment of acetabular fracture(s) Remove J1 5114 involving anterior or posterior (one) from the column, or a fracture running transversely IPO across the acetabulum, with internal fixation 27228 Open treatment of acetabular fracture(s) Remove J1 5114 involving anterior and posterior (two) from the columns, includes t-fracture and both IPO column fracture with complete articular detachment, or single column or transverse fracture with associated acetabular wall fracture, with internal fixation 27232 Closed treatment of femoral fracture, Remove J1 5112 proximal end, neck; with manipulation, with from the or without skeletal traction IPO 27236 Open treatment of femoral fracture, Remove J1 5114 proximal end, neck, internal fixation or from the prosthetic replacement IPO 27240 Closed treatment of intertrochanteric, Remove J1 5112 peritrochanteric, or subtrochanteric femoral from the fracture; with manipulation, with or without IPO skin or skeletal traction 27244 Treatment of intertrochanteric, Remove J1 5114 peritrochanteric, or subtrochanteric femoral from the fracture; with plate/screw type implant, with IPO or without cerclage 27245 Treatment of intertrochanteric, Remove J1 5114 peritrochanteric, or subtrochanteric femoral from the fracture; with intramedullary implant, with IPO or without interlocking screws and/or cerclage 27248 Open treatment of greater trochanteric Remove J1 5114 fracture, includes internal fixation, when from the performed IPO 27253 Open treatment of hip dislocation, Remove J1 5113 traumatic, without internal fixation from the IPO 27254 Open treatment of hip dislocation, Remove J1 5113 traumatic, with acetabular wall and femoral from the head fracture, with or without internal or IPO external fixation CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 27258 Open treatment of spontaneous hip Remove J1 5113 dislocation (developmental, including from the congenital or pathological), replacement of IPO femoral head in acetabulum (including tenotomy, etc); 27259 Open treatment of spontaneous hip Remove J1 5113 dislocation (developmental, including from the congenital or pathological), replacement of IPO femoral head in acetabulum (including tenotomy, etc); with femoral shaft shortening 27268 Closed treatment of femoral fracture, Remove J1 5113 proximal end, head; with manipulation from the IPO 27269 Open treatment of femoral fracture, Remove J1 5112 proximal end, head, includes internal from the fixation, when performed IPO 27280 Arthrodesis, open, sacroiliac joint, including Remove J1 5116 obtaining bone graft, including from the instrumentation, when performed IPO 27282 Arthrodesis, symphysis pubis (including Remove J1 5115 obtaining graft) from the IPO 27284 Arthrodesis, hip joint (including obtaining Remove J1 5116 graft); from the IPO 27286 Arthrodesis, hip joint (including obtaining Remove J1 5116 graft); with subtrochanteric osteotomy from the IPO 27290 Interpelviabdominal amputation Remove J1 5116 (hindquarter amputation) from the IPO 27295 Detachment of hip joint Remove J1 5116 from the IPO 27303 Incision, deep, with opening of bone cortex, Remove J1 5114 femur or knee (eg, osteomyelitis or bone from the abscess) IPO 27365 Radical resection of tumor, femur or knee Remove J1 5114 from the IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 27445 Arthroplasty, knee, hinge prosthesis (eg, Remove J1 5115 walldius type) from the IPO 27448 Osteotomy, femur, shaft or supracondylar; Remove J1 5114 without fixation from the IPO 27450 Osteotomy, femur, shaft or supracondylar; Remove J1 5114 with fixation from the IPO 27454 Osteotomy, multiple, with realignment on Remove J1 5114 intramedullary rod, femoral shaft (eg, from the sofield type procedure) IPO 27455 Osteotomy, proximal tibia, including fibular Remove J1 5114 excision or osteotomy (includes correction from the of genu varus [bowleg] or genu valgus IPO [knock-knee]); before epiphyseal closure 27457 Osteotomy, proximal tibia, including fibular Remove J1 5114 excision or osteotomy (includes correction from the of genu varus [bowleg] or genu valgus IPO [knock-knee]); after epiphyseal closure 27465 Osteoplasty, femur; shortening (excluding Remove J1 5114 64876) from the IPO 27466 Osteoplasty, femur; lengthening Remove J1 5114 from the IPO 27468 Osteoplasty, femur; combined, lengthening Remove J1 5114 and shortening with femoral segment from the transfer IPO 27470 Repair, nonunion or malunion, femur, distal Remove J1 5114 to head and neck; without graft (eg, from the compression technique) IPO 27472 Repair, nonunion or malunion, femur, distal Remove J1 5114 to head and neck; with iliac or other from the autogenous bone graft (includes obtaining IPO graft) 27486 Repair, nonunion or malunion, femur, distal Remove J1 5115 to head and neck; with iliac or other from the autogenous bone graft (includes obtaining IPO graft) CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 27487 Revision of total knee arthroplasty, with or Remove J1 5115 without allograft; femoral and entire tibial from the component IPO 27488 Removal of prosthesis, including total knee Remove J1 5114 prosthesis, methylmethacrylate with or from the without insertion of spacer, knee IPO 27495 Prophylactic treatment (nailing, pinning, Remove J1 5114 plating, or wiring) with or without from the methylmethacrylate, femur IPO 27506 Open treatment of femoral shaft fracture, Remove J1 5114 with or without external fixation, with from the insertion of intramedullary implant, with or IPO without cerclage and/or locking screws 27507 Open treatment of femoral shaft fracture Remove J1 5114 with plate/screws, with or without cerclage from the IPO 27511 Open treatment of femoral supracondylar or Remove J1 5114 transcondylar fracture without intercondylar from the extension, includes internal fixation, when IPO performed 27513 Open treatment of femoral supracondylar or Remove J1 5114 transcondylar fracture with intercondylar from the extension, includes internal fixation, when IPO performed 27514 Open treatment of femoral fracture, distal Remove J1 5114 end, medial or lateral condyle, includes from the internal fixation, when performed IPO 27519 Open treatment of femoral fracture, distal Remove J1 5114 end, medial or lateral condyle, includes from the internal fixation, when performed IPO 27535 Open treatment of tibial fracture, proximal Remove J1 5114 (plateau); unicondylar, includes internal from the fixation, when performed IPO 27536 Open treatment of tibial fracture, proximal Remove J1 5114 (plateau); bicondylar, with or without from the internal fixation IPO 27540 Open treatment of intercondylar spine(s) Remove J1 5114 and/or tuberosity fracture(s) of the knee, from the includes internal fixation, when performed IPO 27556 Open treatment of knee dislocation, includes Remove J1 5114 internal fixation, when performed; without from the IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator primary ligamentous repair or augmentation/reconstruction 27557 Open treatment of knee dislocation, includes Remove J1 5114 internal fixation, when performed; with from the primary ligamentous repair IPO 27558 Open treatment of knee dislocation, includes Remove J1 5114 internal fixation, when performed; with from the primary ligamentous repair IPO 27580 Arthrodesis, knee, any technique Remove J1 5115 from the IPO 27590 Amputation, thigh, through femur, any Remove J1 5116 level; from the IPO 27591 Amputation, thigh, through femur, any Remove J1 5116 level; immediate fitting technique including from the first cast IPO 27592 Amputation, thigh, through femur, any Remove J1 5116 level; open, circular (guillotine) from the IPO 27596 Amputation, thigh, through femur, any Remove J1 5114 level; re-amputation from the IPO 27598 Disarticulation at knee Remove J1 5115 from the IPO 27645 Radical resection of tumor; tibia Remove J1 5114 from the IPO 27646 Radical resection of tumor; fibula Remove J1 5114 from the IPO 27702 Arthroplasty, ankle; with implant (total Remove J1 5115 ankle) from the IPO 27703 Arthroplasty, ankle; revision, total ankle Remove J1 5115 from the IPO 27712 Osteotomy; multiple, with realignment on Remove J1 5115 intramedullary rod (eg, sofield type from the procedure) IPO CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator 27715 Osteoplasty, tibia and fibula, lengthening or Remove J1 5115 shortening from the IPO 27724 Repair of nonunion or malunion, tibia; with Remove J1 5114 iliac or other autograft (includes obtaining from the graft) IPO 27725 Repair of nonunion or malunion, tibia; by Remove J1 5114 synostosis, with fibula, any method from the IPO 27727 Repair of congenital pseudarthrosis, tibia Remove J1 5114 from the IPO 27880 Amputation, leg, through tibia and fibula; Remove J1 5116 from the IPO 27881 Amputation, leg, through tibia and fibula; Remove J1 5114 with immediate fitting technique including from the application of first cast IPO 27882 Amputation, leg, through tibia and fibula; Remove J1 5114 open, circular (guillotine) from the IPO 27886 Amputation, leg, through tibia and fibula; Remove J1 5114 re-amputation from the IPO 27888 Amputation, ankle, through malleoli of tibia Remove J1 5115 and fibula (eg, syme, pirogoff type from the procedures), with plastic closure and IPO resection of nerves 28800 Amputation, foot; midtarsal (eg, chopart Remove J1 5113 type procedure) from the IPO G0412 Open treatment of iliac spine(s), tuberosity Remove J1 5114 avulsion, or iliac wing fracture(s), unilateral from the or bilateral for pelvic bone fracture patterns IPO which do not disrupt the pelvic ring includes internal fixation, when performed G0414 Open treatment of anterior pelvic bone Remove J1 5115 fracture and/or dislocation for fracture from the patterns which disrupt the pelvic ring, IPO unilateral or bilateral, includes internal fixation when performed (includes pubic symphysis and/or superior/inferior rami) CY CY 2021 Long Descriptor Final CY 2021 CY 2021 2021 Action OPPS OPPS APC CPT Status Assignment Code Indicator G0415 Open treatment of posterior pelvic bone Remove J1 5115 fracture and/or dislocation, for fracture from the patterns which disrupt the pelvic ring, IPO unilateral or bilateral, includes internal fixation, when performed (includes ilium, sacroiliac joint and/or sacrum)

Table 11. ─ Elimination of Selected National Coverage Determinations (NCDs) Effective January 1, 2021 NCD Manual Name of NCD Citation 20.5 Extracorporeal Immunoadsorption (ECI) Using Protein A Columns 30.4 Electrosleep Therapy 100.9 Implantation of Gastroesophageal Reflux Device 110.19 Abarelix for the Treatment of Prostate Cancer 220.2.1 Mangenetic Resonance Spectroscopy 220.6.16 FDG PET for Inflammation and Infection

Table 12. ─ Revised OPPS SI and/or APCs for Designated NCDs HCPCS OPPS OPPS Long Descriptor Code SI APC 76390 Magnetic resonance spectroscopy S 5521 Magnetic resonance spectroscopy, determination and localization of discogenic pain (cervical, thoracic, or lumbar); 0609T acquisition of single voxel data, per disc, on biomarkers (ie, Q3 5523 lactic acid, carbohydrate, alanine, laal, propionic acid, proteoglycan, and collagen) in at least 3 discs Magnetic resonance spectroscopy, determination and 0610T localization of discogenic pain (cervical, thoracic, or lumbar); N N/A transmission of biomarker data for software analysis Magnetic resonance spectroscopy, determination and localization of discogenic pain (cervical, thoracic, or lumbar); 0611T S 5523 postprocessing for algorithmic analysis of biomarker data for determination of relative chemical differences between discs Magnetic resonance spectroscopy, determination and 0612T localization of discogenic pain (cervical, thoracic, or lumbar); M N/A interpretation and report G0235 Pet imaging, any site, not otherwise specified S 5591

Table 13. – Long Descriptors and Effective Dates for the OTP ─ related HCPCS codes HCPCS Long Descriptor Effective Code Date G2067 Medication assisted treatment, methadone; weekly bundle 1/1/2020 including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a medicare- enrolled opioid treatment program) G2068 Medication assisted treatment, buprenorphine (oral); weekly 1/1/2020 bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare- enrolled opioid treatment program)

G2069 Medication assisted treatment, buprenorphine (injectable); 1/1/2020 weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program) G2070 Medication assisted treatment, buprenorphine (implant 1/1/2020 insertion); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program) G2071 Medication assisted treatment, buprenorphine (implant 1/1/2020 removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)

G2072 Medication assisted treatment, buprenorphine (implant 1/1/2020 insertion and removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)

G2073 Medication assisted treatment, naltrexone; weekly bundle 1/1/2020 including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare- enrolled opioid treatment program)

HCPCS Long Descriptor Effective Code Date G2074 Medication assisted treatment, weekly bundle not including 1/1/2020 the drug, including substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)

G2075 Medication assisted treatment, medication not otherwise 1/1/2020 specified; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a medicare-enrolled opioid treatment program)

G2076 Intake activities, including initial medical examination that is 1/1/2020 a complete, fully documented physical evaluation and initial assessment by a program physician or a primary care physician, or an authorized healthcare professional under the supervision of a program physician qualified personnel that includes preparation of a treatment plan that includes the patient's short-term goals and the tasks the patient must perform to complete the short-term goals; the patient's requirements for education, vocational rehabilitation, and employment; and the medical, psycho- social, economic, legal, or other supportive services that a patient needs, conducted by qualified personnel (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure

G2077 Periodic assessment; assessing periodically by qualified 1/1/2020 personnel to determine the most appropriate combination of services and treatment (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure

G2078 Take-home supply of methadone; up to 7 additional day 1/1/2020 supply (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure

G2079 Take-home supply of buprenorphine (oral); up to 7 additional 1/1/2020 day supply (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure

HCPCS Long Descriptor Effective Code Date G2080 Each additional 30 minutes of counseling in a week of 1/1/2020 medication assisted treatment, (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure

G2215 Take-home supply of nasal naloxone (provision of the 01/01/2021 services by a Medicare-enrolled Opioid Treatment Program); List separately in addition to code for primary procedure

G2216 Take-home supply of injectable naloxone (provision of the 01/01/2021 services by a Medicare-enrolled Opioid Treatment Program); List separately in addition to code for primary procedure

Table 14. – Change to the Status Indicator for HCPCS code P9099 Effective January 1, 2021 Old Old New New HCPCS Short Descriptor Long Descriptor 2020 2020 2021 2021 Code APC SI SI APC Blood Blood component or P9099 component/product product not otherwise N/A E2 R 9537 noc classified

Table 15. ─ New CY 2021 HCPCS Codes Effective January 1, 2021 for Certain Drugs, Biologicals, and Radiopharmaceuticals Receiving Pass-Through Status CY 2021 CY CY HCPCS CY 2021 Long Descriptor 2021 2021 Code SI APC C9068 Copper Cu-64, dotatate, diagnostic, 1 millicurie G 9383 C9069 Injection, belantamab mafodontin-blmf, 0.5 mg G 9384 C9070 Injection, tafasitamab-cxix, 2 mg G 9385 C9071 Injection, viltolarsen, 10 mg G 9386 C9072 Injection, immune globulin (asceniv), 500 mg G 9392 C9073 Brexucabtagene autoleucel, up to 200 million autologous anti- G 9391 cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose CY 2021 CY CY HCPCS CY 2021 Long Descriptor 2021 2021 Code SI APC J0693 Injection, cefiderocol, 5 mg G 9380 J9223 Injection, lurbinectedin, 0.1 mg G 9389 J9316 Injection, pertuzumab, trastuzumab, and hyaluronidase-zzxf, per G 9390 10 mg

Table 16. ─ Existing HCPCS Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals Receiving Pass-Through Status Effective January 1, 2021 CY 2021 October January CY HCPCS CY 2021 Long Descriptor 2020 2021 SI 2021 Code SI APC J1437 Injection, ferric derisomaltose, 10 mg K G 9388 J9198 Gemcitabine hydrochloride, (infugem), 100 mg N G 9387

Table 17. ─ HCPCS Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals with Pass-Through Status Ending Effective December 31, 2020

CY 2021 October January January HCPCS CY 2021 Long Descriptor 2021 SI 2021 SI 2021 Code APC J0567 Injection, cerliponase alfa, 1 mg G N N/A J0599 Injection, c-1 esterase inhibitor (human), G K 9015 (haegarda), 10 units J1628 Injection, guselkumab, 1 mg G K 9029 J3316 Injection, triptorelin, extended-release, 3.75 mg G K 9016 J7345 Aminolevulinic acid hcl for topical G K 9301 administration, 10% gel, 10 mg J9153 Injection, liposomal, 1 mg daunorubicin and 2.27 G K 9302 mg cytarabine J9203 Injection, gemtuzumab ozogamicin, 0.1 mg G K 9495 J9229 Injection, inotuzumab ozogamicin, 0.1 mg G K 9028

Table 18. ─ Drugs and Biologicals that Will Retroactively Change from Non-Payable Status to Separately Payable Status from October 1, 2020 to December 31, 2020

HCPCS Old New Effective Date Long Descriptor APC Code SI SI J1437 Injection, ferric derisomaltose, E2 K 9388 10/01/2020 10 mg

Table 19. ─ Newly Established HCPCS Codes for Drugs, Biologicals, and Radiopharmaceuticals as of January 1, 2021 New Old HCPCS HCPCS Long Descriptor SI APC Code Code 90377 N/A Rabies immune globulin, heat- and solvent/detergent- E2 N/A treated (RIg-HT S/D), human, for intramuscular and/or subcutaneous use A9591 C9060 Fluoroestradiol F 18, diagnostic, 1 millicurie G 9370 C9068 N/A Copper Cu-64, dotatate, diagnostic, 1 millicurie G 9383 C9069 N/A Injection, belantamab mafodontin-blmf, 0.5 mg G 9384 C9070 N/A Injection, tafasitamab-cxix, 2 mg G 9385 C9071 N/A Injection, viltolarsen, 10 mg G 9386 C9072 N/A Injection, immune globulin (asceniv), 500 mg G 9392 C9073 N/A Brexucabtagene autoleucel, up to 200 million G 9391 autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose J0693 N/A Injection, cefiderocol, 5 mg G 9380 J1823 N/A Injection, inebilizumab-cdon, 1 mg K 9394 J7212 N/A Factor viia (antihemophilic factor, recombinant)-jncw K 9395 (sevenfact), 1 microgram J7352 N/A Afamelanotide implant, 1 mg K 9396 J9144 C9062 Injection, daratumumab, 10 mg and hyaluronidase- G 9378 fihj J9223 N/A Injection, lurbinectedin, 0.1 mg G 9389 J9281 C9064 Mitomycin pyelocalyceal instillation, 1 mg G 9374 J9316 N/A Injection, pertuzumab, trastuzumab, and G 9390 hyaluronidase-zzxf, per 10 mg J9317 C9066 Injection, sacituzumab govitecan-hziy, 2.5 mg G 9376 Q5122 N/A Injection, pegfilgrastim-apgf, biosimilar, (nyvepria), E2 N/A 0.5 mg

Table 20. ─ Restatement of the payment rate for HCPCS code A9600 (Strontium sr-89 chloride, therapeutic, per millicurie) for the period October 1, 2020 through December 31, 2020

HCPCS Original New Payment Effective Date Long Descriptor Code Payment Rate Rate A9600 Strontium sr-89 chloride, $2,045.702 $3,975.000 10/01/2020 – therapeutic, per millicurie 12/31/2020

Table 21. — Skin Substitute Assignments to High Cost and Low Cost Groups for CY 2021 CY CY 2020 Final CY 2021 2021 High/Low CY 2021 Short Descriptor High/Low Cost HCPCS Cost Assignment Code Assignment C1849 Skin substitute, synthetic High High C9363 Integra meshed bil wound mat High High* Q4100 Skin substitute, nos Low Low Q4101 Apligraf High High Q4102 Oasis wound matrix Low Low Q4103 Oasis burn matrix High High* Q4104 Integra bmwd High High Q4105 Integra drt or omnigraft High High Q4106 Dermagraft High High Q4107 Graftjacket High High Q4108 Integra matrix High High* Q4110 Primatrix High High* Q4111 Gammagraft Low Low Q4115 Alloskin Low Low Q4116 Alloderm High High Q4117 Hyalomatrix Low Low Q4121 Theraskin High High* Q4122 Dermacell, awm, porous sq cm High High Q4123 Alloskin High High Q4124 Oasis tri-layer wound matrix Low Low Q4126 Memoderm/derma/tranz/integup High High Q4127 Talymed High High* Q4128 Flexhd/allopatchhd/matrixhd High High Q4132 Grafix core, grafixpl core High High Q4133 Grafix stravix prime pl sqcm High High Q4134 Hmatrix Low Low CY CY 2020 Final CY 2021 2021 High/Low CY 2021 Short Descriptor High/Low Cost HCPCS Cost Assignment Code Assignment Q4135 Mediskin Low Low Q4136 Ezderm Low Low Q4137 Amnioexcel biodexcel, 1 sq cm High High Q4138 Biodfence dryflex, 1cm High High Q4140 Biodfence 1cm High High Q4141 Alloskin ac, 1cm High High* Q4143 Repriza, 1cm High High Q4146 Tensix, 1cm High High Q4147 Architect ecm px fx 1 sq cm High High Q4148 Neox neox rt or clarix cord High High Q4150 Allowrap ds or dry 1 sq cm High High Q4151 Amnioband, guardian 1 sq cm High High Q4152 Dermapure 1 square cm High High Q4153 Dermavest, plurivest sq cm High High Q4154 Biovance 1 square cm High High Q4156 Neox 100 or clarix 100 High High Q4157 Revitalon 1 square cm High High* Q4158 Kerecis omega3, per sq cm High High* Q4159 Affinity 1 square cm High High Q4160 Nushield 1 square cm High High Q4161 Bio-connekt per square cm High High Q4163 Woundex, bioskin, per sq cm High High Q4164 Helicoll, per square cm High High Q4165 Keramatrix, kerasorb sq cm Low Low Q4166 Cytal, per square centimeter Low Low Q4167 Truskin, per square centimeter Low High Q4169 Artacent wound, per sq cm High High Q4170 Cygnus, per sq cm Low Low Q4173 Palingen or palingen xplus High High Q4175 Miroderm High High Q4176 Neopatch, per sq centimeter High High Q4178 Floweramniopatch, per sq cm High High Q4179 Flowerderm, per sq cm High High Q4180 Revita, per sq cm High High Q4181 Amnio wound, per square cm High High Q4182 Transcyte, per sq centimeter Low High Q4183 Surgigraft, 1 sq cm High High Q4184 Cellesta or duo per sq cm High High* Q4186 Epifix 1 sq cm High High Q4187 Epicord 1 sq cm High High Q4188 Amnioarmor 1 sq cm Low High CY CY 2020 Final CY 2021 2021 High/Low CY 2021 Short Descriptor High/Low Cost HCPCS Cost Assignment Code Assignment Q4190 Artacent ac 1 sq cm Low High Q4191 Restorigin 1 sq cm Low Low Q4193 Coll-e-derm 1 sq cm Low High Q4194 Novachor 1 sq cm High High* Q4195 Puraply 1 sq cm High High Q4196 Puraply am 1 sq cm High High Q4197 Puraply xt 1 sq cm High High Q4198 Genesis amnio membrane 1 Low High sqcm Q4200 Skin te 1 sq cm Low High Q4201 Matrion 1 sq cm Low Low Q4203 Derma-gide, 1 sq cm High High* Q4204 Xwrap 1 sq cm Low Low Q4205 Membrane graft or wrap sq cm High High Q4208 Novafix per sq cm High High Q4209 Surgraft per sq cm Low High Q4210 Axolotl graf dualgraf sq cm Low Low Q4211 Amnion bio or axobio sq cm Low High Q4214 Cellesta cord per sq cm Low Low Q4216 Artacent cord per sq cm Low Low Q4217 Woundfix biowound plus xplus Low Low Q4218 Surgicord per sq cm Low Low Q4219 Surgigraft dual per sq cm Low High Q4220 Bellacell hd, surederm sq cm Low Low Q4221 Amniowrap2 per sq cm Low Low Q4222 Progenamatrix, per sq cm Low High Q4226 Myown harv prep proc sq cm High High Q4227 Amniocore per sq cm Low High Q4228 Bionextpatch, per sq cm Low Low Q4229 Cogenex amnio memb per sq Low Low cm Q4232 Corplex, per sq cm Low High Q4234 Xcellerate, per sq cm High High Q4235 Amniorepair or altiply sq cm Low Low Q4236 Carepatch per sq cm Low Low Q4237 Cryo-cord, per sq cm Low High Q4238 Derm-maxx, per sq cm Low High Q4239 Amnio-maxx or lite per sq cm Low High Q4247 Amniotext patch, per sq cm Low Low Q4248 Dermacyte amn mem allo sq cm Low Low Q4249 Amniply, per sq cm Low High CY CY 2020 Final CY 2021 2021 High/Low CY 2021 Short Descriptor High/Low Cost HCPCS Cost Assignment Code Assignment Q4250 AmnioAMP-MP per sq cm Low Low Q4254 Novafix dl per sq cm Low Low Q4255 Reguard, topical use per sq Low Low * These products do not exceed either the proposed MUC or PDC threshold for CY 2021, but are assigned to the high cost group because they were assigned to the high cost group in CY 2020.